FDA 510(k) Application Details - K220138

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K220138
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant LED SpA
Via Selciatella, 40
Aprilia 04011 IT
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Contact Amalia Lamberti
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 01/18/2022
Decision Date 10/05/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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