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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 K183610
Device Name Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces
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 Topaz Kirlew
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/26/2018
Decision Date 03/12/2019
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
Recalls CDRH Recalls
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