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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
510(k) Number K013764
Device Name IMMIX BONE GRAFT EXTENDER
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 Number878.3500
Classification Product Code
KKY  
Subsequent Product Code
LYC  
Date Received11/13/2001
Decision Date 05/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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