FDA 510(k) Application Details - K022461

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K022461
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant HOWMEDICA OSTEONICS
59 ROUTE 17
ALLENDALE, NJ 07401-1677 US
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Contact KAREN ARIEMMA
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 07/26/2002
Decision Date 08/22/2002
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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