FDA 510(k) Application Details - K202880

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K202880
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Apyx Medical Corporation (formerly Bovie Medical Corporation
5115 Ulmerton Road
Clearwater, FL 33760-4004 US
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Contact Lauren Tiller
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 09/28/2020
Decision Date 01/04/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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