FDA 510(k) Application Details - K001228

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K001228
Device Name Pin, Fixation, Threaded
Applicant IMMEDICA, INC.
100 PASSAIC AVE.
CHATHAM, NJ 07928-2848 US
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Contact ROY BOGERT
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 04/17/2000
Decision Date 07/07/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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