FDA 510(k) Application Details - K041288

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K041288
Device Name Pin, Fixation, Smooth
Applicant LINVATEC BIOMATERIALS, INC.
P.O. BOX 3
HERMIANKATU 6-8L
TAMPERE FIN-33720 FI
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Contact TUIJA ANNALA
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 05/13/2004
Decision Date 06/10/2004
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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