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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Animal Source
510(k) Number K092428
Device Name BIO-OSS COLLAGEN
Applicant
Ed. Geistlich Soehne AG Fuer Chemische Industrie
1300 I St., NW, 11th Floor E.
Washington,  DC  20005
Applicant Contact PETER REICHERTZ
Correspondent
Ed. Geistlich Soehne AG Fuer Chemische Industrie
1300 I St., NW, 11th Floor E.
Washington,  DC  20005
Correspondent Contact PETER REICHERTZ
Regulation Number872.3930
Classification Product Code
NPM  
Date Received08/07/2009
Decision Date 03/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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