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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name barrier, animal source, intraoral
510(k) Number K171050
Device Name Geistlich Fibro-Gide
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH 6110
Applicant Contact Marco Steiner
Correspondent
Hogan Lovells US LLP
1835 Market Street, 29th Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number872.3930
Classification Product Code
NPL  
Date Received04/07/2017
Decision Date 11/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Clinical Trials NCT02356770
Reviewed by Third Party No
Combination Product No
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