FDA 510(k) Application Details - K073674

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K073674
Device Name Pin, Fixation, Smooth
Applicant SIGNAL MEDICAL CORP.
400 PYRAMID DR.
MARYSVILLE, MI 48040 US
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Contact LOUIS A SERAFIN
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 12/28/2007
Decision Date 03/24/2008
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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