FDA 510(k) Application Details - K993106

Device Classification Name Plate, Fixation, Bone

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510(K) Number K993106
Device Name Plate, Fixation, Bone
Applicant SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
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Contact JANET JOJNSON GREEN
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 09/17/1999
Decision Date 12/09/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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