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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(k) Number K024199
Device Name IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
Applicant
OSTEOBIOLOGICS, INC.
UNIVERSITY BUSINESS PARK
12500 NETWORK, SUITE 112
SAN ANTONIO,  TX  78249 -3308
Applicant Contact GABRIELE G NIEDERAUER
Correspondent
OSTEOBIOLOGICS, INC.
UNIVERSITY BUSINESS PARK
12500 NETWORK, SUITE 112
SAN ANTONIO,  TX  78249 -3308
Correspondent Contact GABRIELE G NIEDERAUER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/20/2002
Decision Date 03/14/2003
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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