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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 WEST DR.
FORT WORTH,  TX  76132
Applicant Contact RICHARD A HAMER
Correspondent
OSTEOGENICS BIOMEDICAL, INC.
6401 MEADOWS WEST 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
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