Harmony Cone Ear Candles - Citizen Petition

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Harmony Cone Ear Candles Citizen Petition

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Authors: cdrh
 

Exhibit 1 Melting Point of Paraffin Wax

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Exhibit 2 HP Wax Material Safety Data Sheet

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Exhibit 3 Oil Content of Paraffin Wax

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Exhibit 4 Safety of Paraffin Wax

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Exhibit 5 Dripping Wax

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Exhibit 6 Environmental Friendliness of Paraffin Wax

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Exhibit 7 IMO Certificate

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Exhibit 8 HCEC Safety

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Exhibit 9 US Design Patent Patent No US D592 748 S

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Exhibit 10 HCEC Step By Step Instructions

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Exhibit 11 Myth That Ear Candles Are Used for Removing Ear Wax

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Exhibit 12 MHRA Has Specifically Determined That Harmony Cone Ear Candles are not Medical Devices

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Exhibit 13 Classification of Product No Translation Available

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Exhibit 14 Therapeutic Goods Administration of Australia Has also Determined That Ear Candles are for Relaxation and Well being...

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Exhibit 15 Seely et al Ear Candles Efficacy and Safety

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Exhibit 16 State of Alaska Dept of Public Safety Fire Report 05 0007122

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Exhibit 17 DHS US Fire Administration Candle Fires in Residential Structures

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Exhibit 18 US District Court Holistic Candlers and Consumers Association et al vs FDA

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Exhibit 19 Exhibit 18 US District Court Holistic Candlers and Consumers Association et al vs FDA Part 2

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Exhibit 20 Letter from Consumer

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Exhibit 21 MAUDE Adverse Event Report Lee Candles Inc

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Exhibit 22 MAUDE Adverse Event Report Wally Wally Ear Candle

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Exhibit 23 MAUDE Adverse Event Report

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Exhibit 24 MAUDE Adverse Event Report Wally Natural Products

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Exhibit 25 MAUDE Adverse Event Report Local Health Food Store Ear Candle

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Exhibit 26 Richard Harris PhD Untoward Otological and Audiological Consequences of Ear Candling

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Exhibit 27 Customer Complaint Forms for Consumer Safety and Injury from Harmony Cone

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Exhibit 28 Marketing and Education Resolution Form by Harmony Candles

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Exhibit 29 Label from Harmony Candle

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Exhibit 30 Consumer Updates Source Unknown

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ID: FDA-2013-P-1297-0001

Document Information

Date Posted: Nov 18, 2013
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Submitter Information

Category: Private Industry - C0003

Comments

23
Comments Received*
I enjoy using ear candles when I don't feel good. They add to my well being. I do not consider them a medical device. I would be devastated if they were not...
In the past I have to visit my doctor's office each two months because my ears. I have a very tinny ear canal Harmony Ear Candles it is a product that I...
The Docket Number is FDA-2013-P-1297/CP1. We are requesting of the FDA to agree that: 1. Ear Candles are not medical devices 2. The proposed raw material...

Docket Information

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