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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 K202880
Device Name J-Plasma Precise FLEX Handpiece
Applicant
Apyx Medical Corporation (formerly Bovie Medical Corporation
5115 Ulmerton Road
Clearwater,  FL  33760 -4004
Applicant Contact Lauren Tiller
Correspondent
Apyx Medical Corporation (formerly Bovie Medical Corporation
5115 Ulmerton Road
Clearwater,  FL  33760 -4004
Correspondent Contact Topaz Kirlew
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/28/2020
Decision Date 01/04/2021
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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