FDA 510(k) Application Details - K212472

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K212472
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Triworks Group SRL
Via Don Giuseppe Mucciardi, 5
Campochiaro 86020 IT
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Contact Elio Piero Berchicci
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 08/06/2021
Decision Date 07/07/2022
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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