FDA 510(k) Application Details - K042761

Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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510(K) Number K042761
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
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Contact NOAH BARTSCH
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 10/05/2004
Decision Date 11/17/2004
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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