FDA 510(k) Application Details - K213607

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K213607
Device Name Dressing, Wound, Collagen
Applicant Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen 6110 CH
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Contact Erik Wirth
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 11/15/2021
Decision Date 04/28/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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