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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 K170777
Device Name Bovie J-Plasma Precise FLEX Handpiece
Applicant
Bovie Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Applicant Contact Rubiela Maldonado
Correspondent
Bovie Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Correspondent Contact Rubiela Maldonado
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/15/2017
Decision Date 05/01/2017
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
Predetermined Change
Control Plan Authorized		 No
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