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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
Applicant Contact NED DEVINE
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/22/2012
Decision Date 03/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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