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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 K151797
Device Name Nuocande Plastic Manual Wheelchair Model NKD L07
Applicant
Ningbo Lecount Medical Technology Co., Ltd.
57 Longfei Rd., Yunlong Industry Zone, Yingzhou District
Ningbo,  CN 315135
Applicant Contact CHARLES SHEN
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact CHARLES SHEN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/02/2015
Decision Date 08/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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