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FDA 510(k) Application Details - K082381
Device Classification Name
Filler, Bone Void, Calcium Compound
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510(K) Number
K082381
Device Name
Filler, Bone Void, Calcium Compound
Applicant
BIOCOMPOSITES LTD.
KEELE SCIENCE PARK
KEELE, STAFFORDSHIRE ST5 5NL GB
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Contact
SIMON FITZER
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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
08/19/2008
Decision Date
11/14/2008
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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