FDA 510(k) Application Details - K032427

Device Classification Name Component, Traction, Invasive

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510(K) Number K032427
Device Name Component, Traction, Invasive
Applicant MERIDAN MEDICAL
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact GREG HOLLAND
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Regulation Number 888.3040

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Classification Product Code JEC
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Date Received 08/06/2003
Decision Date 10/09/2003
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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