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FDA 510(k) Application Details - K081428
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K081428
Device Name
Screw, Fixation, Bone
Applicant
BIOCOMPOSITES LTD.
KEELE SCIENCE PARK
KEELE, STAFFORDSHIRE ST5 5NL GB
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Contact
SIMON FITZER
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/21/2008
Decision Date
06/20/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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