FDA 510(k) Application Details - K232146

Device Classification Name

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510(K) Number K232146
Device Name Anovo Pedestal
Applicant Momentis Surgical Ltd.
3 Yahadut Canada St.
Or Yehuda 6037503 IL
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Contact Maya Leib Shlomo
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Regulation Number

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Classification Product Code QNM
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Date Received 07/19/2023
Decision Date 09/14/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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