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FDA 510(k) Application Details - K032447
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K032447
Device Name
Screw, Fixation, Bone
Applicant
LINVATEC BIOMATERIALS, LTD.
HERMIANKATU 6-8L
TAMPERE FI
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Contact
TUIJA ANNALA
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
08/08/2003
Decision Date
04/16/2004
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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