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FDA 510(k) Application Details - K080511
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K080511
Device Name
Filler, Bone Void, Calcium Compound
Applicant
OSTEOTECH, INC.
51 JAMES WAY
EATONTOWN, NJ 07724 US
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Contact
CHRIS TALBOT
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/25/2008
Decision Date
04/21/2008
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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