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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K171842
Device Name Geistlich Wound Matrix
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH CH-6110
Applicant Contact Jan van der Ploeg
Correspondent
Biologics Consulting Group, Inc.
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact Stephen P. Rhodes
Classification Product Code
KGN  
Subsequent Product Code
NPL  
Date Received06/20/2017
Decision Date 11/03/2017
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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