BioElectronics Corporation - Change in Classification Petition
This Other document was issued by the Food and Drug Administration (FDA)
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Enclosure 1 Specification for Which Reclassification is Requested 860 123 a 1
Enclosure 5 Statement for Disagreement with Present Classification 860 123 a 5
Enclosure 7 3 Nicolle et al Use of Radio Frequency Pulsed Energy in the Control of Postoperative Reaction in Blepharoplasty
Enclosure 9 Summary of New Info Under Section 513 e 514 b or 515 b 860 123 a 8
Enclosure 10 Source Documents From Which New Information Obtained 860 123 a 10
Appendix A Supplemental Data Sheet General Device Classification Questionnaire
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Comment Period Closed
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Date Posted: Aug 14, 2012
Category: Private Industry - C0003
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RE: BioElectronics Corporation - Change in Classification Petition FDA-2012-N-0378-0001/CCP – Comments To: Device Group, FDA From: Lawrence L. Michaelis, M.D...
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