FDA 510(k) Application Details - K960483

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K960483
Device Name Pin, Fixation, Smooth
Applicant AMERICAN MEDICAL SPECIALTIES, INC.
6090-H MCDONOUGH DR.
NORCROSS, GA 30093 US
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Contact ROGER EAGLEN
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 02/02/1996
Decision Date 04/09/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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