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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
Applicant Contact GABRIELE G NIEDERAUER
Correspondent
Osteobiologics, Inc.
University Business Park
12500 Network, Suite 112
San Antonio,  TX  78249
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
Predetermined Change
Control Plan Authorized		 No
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