510(k) K043172

TRUGRAFT BGS SYRINGE, MODEL 600-041 by Osteobiologics, Inc. — Product Code FMF

K043172 is an FDA 510(k) premarket notification submitted by Osteobiologics, Inc. for the device "TRUGRAFT BGS SYRINGE, MODEL 600-041". The FDA issued a decision of Substantially Equivalent on January 7, 2005. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Osteobiologics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2005
Date Received
November 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type