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FDA 510(k) Application Details - K023160
Device Classification Name
Equipment, Traction, Powered
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5900
More FDA Info for this Regulation Number
Classification Product Code
ITH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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