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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K203496
Device Name Nexo-Gide Bilayer Collagen Membrane
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH 6110
Applicant Contact Marco Steiner
Correspondent
Biologics Consulting
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Joshua Crist
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OWW  
Date Received11/27/2020
Decision Date 07/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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