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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 K142975
Device Name Bovie Ultimate High Frequency Electrosurgical Generator
Applicant
Bovie Medical Corporation
5115 Ulmerton Road
Clearwater,  FL  33760
Applicant Contact Moshe Citronowicz
Correspondent
Bovie Medical Corporation
5115 Ulmerton Road
Clearwater,  FL  33760
Correspondent Contact Moshe Citronowicz
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/14/2014
Decision Date 12/12/2014
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
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