FDA 510(k) Application Details - K210942

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K210942
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Integra MicroFrance
Le Pavillon
Saint Aubin Le Monial Allier 03160 FR
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Contact Malena Zammetti
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 03/30/2021
Decision Date 05/14/2021
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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