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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name massager, powered inflatable tube
510(k) Number K112890
Model PPS-101
Device Name NORMATEC MVP
Original Applicant
NORMATEC INDUSTRIES, LP
555 thirteenth street, nw
washington,  DC  20016
Original Contact jonathan kahan
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
JOW  
Date Received09/30/2011
Decision Date 01/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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