FDA 510(k) Application Details - K222260

Device Classification Name

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510(K) Number K222260
Device Name Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500
Applicant Capenergy Medical S.L.
Avinguda Mare de DΘu de Montserrat, 41
Sant Joan Despi, Barcelona 08970 ES
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Contact Pilar Sanchez
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Regulation Number

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Classification Product Code PBX
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Date Received 07/28/2022
Decision Date 03/28/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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