FDA 510(k) Application Details - K951493

Device Classification Name Screw, Fixation, Bone

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510(K) Number K951493
Device Name Screw, Fixation, Bone
Applicant AMERICAN MEDICAL ELECTRONICS, INC.
250 EAST ARAPAHO RD.
RICHARDSON, TX US
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Contact MARY BIGGERS
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 03/31/1995
Decision Date 07/03/1995
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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