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FDA 510(k) Application Details - K033231
Device Classification Name
Equipment, Traction, Powered
More FDA Info for this Device
510(K) Number
K033231
Device Name
Equipment, Traction, Powered
Applicant
NORTH AMERICAN MEDICAL CORP (NAM)
3350 RIVERWOOD PKWY.
SUITE 1900
ATLANTA, GA 30339 US
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Contact
GIDGETTE RUBIN
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Regulation Number
890.5900
More FDA Info for this Regulation Number
Classification Product Code
ITH
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More FDA Info for this Product Code
Date Received
10/06/2003
Decision Date
09/09/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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