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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 K120526
Device Name YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR
Applicant
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
333 pfingsten road
northbrook,  IL  60062
Contact ned devine
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/22/2012
Decision Date 03/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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