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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 K012423
Device Name MUCOGRAFT
Applicant
Ed. Geistlich Soehne AG Fuer Chemische Industrie
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact PETER S REICHERTZ
Correspondent
Ed. Geistlich Soehne AG Fuer Chemische Industrie
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact PETER S REICHERTZ
Regulation Number872.3930
Classification Product Code
NPL  
Date Received07/30/2001
Decision Date 01/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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