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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 K152570
Device Name Bovie J-Plasma Precise 360 Handpiece
Applicant
BOVIE MEDICAL CORPORATION
5115 ULMERTON ROAD
CLEARWATER,  FL  33760
Applicant Contact BRIAN KUNST
Correspondent
BOVIE MEDICAL CORPORATION
5115 ULMERTON ROAD
CLEARWATER,  FL  33760
Correspondent Contact BRIAN KUNST
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/09/2015
Decision Date 11/02/2015
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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