FDA 510(k) Application Details - K954667

Device Classification Name Component, Traction, Invasive

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510(K) Number K954667
Device Name Component, Traction, Invasive
Applicant HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD, NJ 07070 US
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Contact JOHN DICHIARA
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Regulation Number 888.3040

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Classification Product Code JEC
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Date Received 10/10/1995
Decision Date 01/11/1996
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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