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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 K191542
Device Name Apyx Plasma/RF Handpiece
Applicant
Bovie Medical Corporation dba Apyx Medical Corporation
5115 Ulmerton Road
clearwater,  FL  33760
Applicant Contact topaz kirlew
Correspondent
Bovie Medical Corporation dba Apyx Medical Corporation
5115 Ulmerton Road
clearwater,  FL  33760
Correspondent Contact topaz kirlew
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/11/2019
Decision Date 10/11/2019
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
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