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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 K052468
Device Name YK9000 SERIES MANUAL WHEELCHAIR
Applicant
Intco Metal Products (Zhenjiang) Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Applicant Contact JOHN ZHAO
Correspondent
Intco Metal Products (Zhenjiang) Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact JOHN ZHAO
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/08/2005
Decision Date 10/05/2005
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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