FDA 510(k) Application Details - K982732

Device Classification Name Plate, Fixation, Bone

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510(K) Number K982732
Device Name Plate, Fixation, Bone
Applicant SYNTHES
1690 RUSSELL RD.
PAOLI, PA 19301 US
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Contact SHERI L MUSGNUNG
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 08/05/1998
Decision Date 10/08/1998
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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