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FDA 510(k) Application Details - K043048
Device Classification Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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510(K) Number
K043048
Device Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Applicant
OSTEOTECH, INC.
51 JAMES WAY
EATONTOWN, NJ 07724 US
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Contact
CHRISTOPHER TALBOT
Other 510(k) Applications for this Contact
Regulation Number
888.3045
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Classification Product Code
MBP
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More FDA Info for this Product Code
Date Received
11/04/2004
Decision Date
11/23/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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