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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 K852199
Device Name OSTEOGRAF 2040 OSTEOGRAF 4060
Applicant
Osteotech, Inc.
1035 Shorline Dr.
San Mateo,  CA  94404
Applicant Contact LOIS HUANG
Correspondent
Osteotech, Inc.
1035 Shorline Dr.
San Mateo,  CA  94404
Correspondent Contact LOIS HUANG
Regulation Number872.3930
Classification Product Code
LYC  
Date Received05/20/1985
Decision Date 10/07/1985
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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