FDA 510(k) Application Details - K915124

Device Classification Name Screw, Fixation, Bone

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510(K) Number K915124
Device Name Screw, Fixation, Bone
Applicant HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD, NJ US
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Contact ROBERT E.SMITH
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 11/13/1991
Decision Date 02/11/1992
Decision SE - Substantially Equivalent
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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