FDA 510(k) Application Details - K221410

Device Classification Name Table, Operating-Room, Ac-Powered

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510(K) Number K221410
Device Name Table, Operating-Room, Ac-Powered
Applicant Moon Surgical
c/o Sofinnova Partners, 7/11 Bd Haussmann
Paris 75009 FR
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Contact Anne Osdoit
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Regulation Number 878.4960

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Classification Product Code FQO
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Date Received 05/16/2022
Decision Date 12/02/2022
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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