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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 K210280
Device Name Geistlich Mucograft®, Geistlich Mucograft® Seal
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH CH-6110
Applicant Contact Marco Steiner
Correspondent
TELOS Partners LLC
571 Christina Lake Drive
Lakeland,  FL  33813
Correspondent Contact Roshana Ahmed
Regulation Number872.3930
Classification Product Code
NPL  
Date Received02/01/2021
Decision Date 03/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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