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FDA 510(k) Application Details - K003954
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K003954
Device Name
Filler, Bone Void, Calcium Compound
Applicant
BIOCOMPOSITES LTD.
ETRUSCAN ST.
ETRURIA
STOKE ON TRENT, STAFFORDSHIRE ST1 5PQ GB
Other 510(k) Applications for this Company
Contact
J. STEPHEN BRATT
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
12/21/2000
Decision Date
07/12/2001
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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