FDA 510(k) Application Details - K151325

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K151325
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant BOVIE MEDICAL CORPORATION
5115 ULMERTON ROAD
CLEARWATER, FL 33760 US
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Contact Brian Kunst
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 05/18/2015
Decision Date 08/04/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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