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FDA 510(k) Application Details - K171842
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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