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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wheelchair, mechanical
510(k) Number K120391
Device Name MR4500 WHEELCHAIR
Original Applicant
WARDRAY PREMISE LTD
7 village woods dr
amherst,  NH  03031
Original Contact james wason ph.d.
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/07/2012
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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