FDA 510(k) Application Details - K171842

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K171842
Device Name Dressing, Wound, Collagen
Applicant Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen CH-6110 CH
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Contact Jan van der Ploeg
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 06/20/2017
Decision Date 11/03/2017
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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