FDA 510(k) Application Details - K040022

Device Classification Name Plate, Fixation, Bone

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510(K) Number K040022
Device Name Plate, Fixation, Bone
Applicant STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact WADE T RUTKOSKIE
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 01/07/2004
Decision Date 03/12/2004
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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