BioElectronics Corporation - Change in Classification Petition

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BioElectronics Corporation Change in Classification Petition

Authors: CDRH
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Enclosure 1 Specification for Which Reclassification is Requested 860 123 a 1

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Enclosure 2 Statement of the Action Requested by the Petitoner 860 123 a 2

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Enclosure 3 Supplemental Data Sheet 860 123 a 3

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Enclosure 4 Completed Classification Questionnaire 860 123 a 4

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Enclosure 5 Statement for Disagreement with Present Classification 860 123 a 5

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Enclosure 6 Full Statement Why not Classified into Class III 860 123 a 6

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Enclosure 7 Overview of the Clinical Studies for this Therapy

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Enclosure 7 3 Nicolle et al Use of Radio Frequency Pulsed Energy in the Control of Postoperative Reaction in Blepharoplasty

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Enclosure 8 Representative Data Unfavorable 860 123 a 7

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Enclosure 9 Summary of New Info Under Section 513 e 514 b or 515 b 860 123 a 8

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Enclosure 10 Source Documents From Which New Information Obtained 860 123 a 10

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Enclosure 11 Financial Certification Disclosure Statement 860 123 a 11

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Appendix A Supplemental Data Sheet General Device Classification Questionnaire

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Appendix B Usability ActiPatch

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Appendix C Bibliography

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Comment Period Closed
ID: FDA-2012-N-0378-0003

Document Information

Date Posted: Aug 14, 2012
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Submitter Information

Category: Private Industry - C0003

Comments

248
Comments Received*
The actipatch is great! i used it myself a couple of times. I didnt think it would work at first, but than realized how much better it is than all the other...
RE: BioElectronics Corporation - Change in Classification Petition FDA-2012-N-0378-0001/CCP – Comments To: Device Group, FDA From: Lawrence L. Michaelis, M.D...
Awesome product. wish it were more readily available.

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