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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 K964342
Device Name CYTOPLAST GBR
Applicant
OSTEOGENICS CO.
100 EAST 15TH STREET,SUITE 320
FORTH WORTH,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
OSTEOGENICS CO.
100 EAST 15TH STREET,SUITE 320
FORTH WORTH,  TX  76102
Correspondent Contact RICHARD A HAMER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received10/31/1996
Decision Date 03/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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