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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, Synthetic
510(k) Number K970321
FOIA Releasable 510(k) K970321
Device Name BIO-OSS ANORGANIC BOVINE BONE
Applicant
Geistlich-Pharma
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact BIRGIT WENZ
Correspondent
Geistlich-Pharma
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact BIRGIT WENZ
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/28/1997
Decision Date 09/15/1998
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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