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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 K871773
Device Name BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANT
Applicant
Geistlich-Pharma
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact PETER S REICHERTZ
Correspondent
Geistlich-Pharma
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact PETER S REICHERTZ
Regulation Number872.3930
Classification Product Code
LYC  
Date Received05/06/1987
Decision Date 08/24/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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