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FDA 510(k) Application Details - K043514
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K043514
Device Name
Filler, Bone Void, Calcium Compound
Applicant
BIOCOMPOSITES LTD.
KEELE SCIENCE PARK
KEELE, STAFFORDSHIRE ST5 5NL GB
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Contact
STEPHEN BRATT
Other 510(k) Applications for this Contact
Regulation Number
888.3045
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Classification Product Code
MQV
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More FDA Info for this Product Code
Date Received
12/20/2004
Decision Date
01/21/2005
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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