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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, cautery, thermal, battery-powered
510(k) Number K121441
Models AA##-NS, AA00,AA02, AA04, AA90, AA01, AA03, AA05, AA09, AA11, AA17, AA21, AA25, AA27, AA29
Device Name CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
Original Applicant
BOVIE MEDICAL CORPORATION
5115 ulmerton road
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clearwater,  FL  33760 0000
Original Contact richard a kozloff
Regulation Number886.4115
Classification Product Code
HQP  
Date Received05/15/2012
Decision Date 07/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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