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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 K993610
Device Name CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
Applicant
Osteogenics Biomedical, Inc.
6401 Meadows W. Dr.
Fort Worth,  TX  76132
Applicant Contact RICHARD A HAMER
Correspondent
Osteogenics Biomedical, Inc.
6401 Meadows W. Dr.
Fort Worth,  TX  76132
Correspondent Contact RICHARD A HAMER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received10/25/1999
Decision Date 03/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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