FDA 510(k) Application Details - K961905

Device Classification Name Screw, Fixation, Bone

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510(K) Number K961905
Device Name Screw, Fixation, Bone
Applicant MEDICINE LODGE, INC.
152 SOUTH 600 WEST
LOGAN, UT 84321 US
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Contact WADE F ALLIN
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 05/16/1996
Decision Date 08/06/1996
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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