FDA 510(k) Application Details - K050275

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K050275
Device Name Pin, Fixation, Smooth
Applicant INION LTD.
LAAKARINKATU 2
TAMPERE 33520 FI
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Contact HANNA MARTTILA
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 02/07/2005
Decision Date 03/07/2005
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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