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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 K843398
Device Name OSTEOGEN
Applicant
Impladent
40-17 82nd. St.
Jackson Heights,  NY  11373 -
Applicant Contact MAURICE VALEN
Correspondent
Impladent
40-17 82nd. St.
Jackson Heights,  NY  11373 -
Correspondent Contact MAURICE VALEN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received08/29/1984
Decision Date 12/27/1984
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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