FDA 510(k) Application Details - K040462

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K040462
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
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Contact KIM KELLY
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 02/23/2004
Decision Date 03/23/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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