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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K161558
Device Name Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating
Applicant
BOVIE MEDICAL CORPORATION
5115 ULMERTON ROAD
CLEARWATER,  FL  33760
Applicant Contact Rubiela Maldonado
Correspondent
BOVIE MEDICAL CORPORATION
5115 ULMERTON ROAD
CLEARWATER,  FL  33760
Correspondent Contact Rubiela Maldonado
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/06/2016
Decision Date 07/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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