FDA 510(k) Application Details - K964024

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K964024
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant DEPUY, INC.
P.O. BOX 988
WARSAW, IN 46581-0988 US
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Contact CHERYL HASTINGS
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 10/07/1996
Decision Date 03/26/1997
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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