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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 K952619
Device Name BIO-OSS CERAMIC
Applicant
Geistlich-Pharma
Arent, Fox, Kintner, Plotkin &
1050 Connecticut Ave.
Washington,  DC  20003
Applicant Contact PETER S REICHERTZ
Correspondent
Geistlich-Pharma
Arent, Fox, Kintner, Plotkin &
1050 Connecticut Ave.
Washington,  DC  20003
Correspondent Contact PETER S REICHERTZ
Regulation Number872.3930
Classification Product Code
LYC  
Date Received06/06/1995
Decision Date 08/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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