FDA 510(k) Application Details - K023160

Device Classification Name Equipment, Traction, Powered

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510(K) Number K023160
Device Name Equipment, Traction, Powered
Applicant AXIOM USA. INC
3830 GUNN HWY
TAMPA, FL 33624 US
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Contact JIM GIBSON
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Regulation Number 890.5900

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Classification Product Code ITH
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Date Received 09/23/2002
Decision Date 12/20/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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