FDA 510(k) Application Details - K200253

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K200253
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Ethicon Endo-Surgery
475 Cale C
Guaynabo, PR 00696 US
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Contact Emily Nesbitt
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 02/03/2020
Decision Date 05/27/2020
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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