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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 K192042
Device Name Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH CH-6110
Applicant Contact Marco Steiner
TELOS Partners, LLC
571 Christina Lake Drive
Lakeland,  FL  33813
Correspondent Contact Roshana Ahmed
Regulation Number872.3930
Classification Product Code
Subsequent Product Code
Date Received07/31/2019
Decision Date 08/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No