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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K043172
Device Name TRUGRAFT BGS SYRINGE, MODEL 600-041
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 Number880.5860
Classification Product Code
FMF  
Date Received11/16/2004
Decision Date 01/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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