FDA 510(k) Application Details - K061607

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K061607
Device Name Pin, Fixation, Smooth
Applicant INTELLIGENT ORTHOPAEDICS LTD
BRIERFIELD MILL
BRIERFIELD, NELSON BB9 5NJ GB
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Contact NEIL MC LACHLAN
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 06/09/2006
Decision Date 07/18/2006
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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