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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 K870043
Device Name GUO GUANG WHEEL CHAIR
Applicant
China National Medicines & Health Prod. I/E Corp.
1000 Thomas Jefferson St. NW
Suite 500
Washington,  DC  20007
Applicant Contact LISA MITNICK
Correspondent
China National Medicines & Health Prod. I/E Corp.
1000 Thomas Jefferson St. NW
Suite 500
Washington,  DC  20007
Correspondent Contact LISA MITNICK
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/05/1987
Decision Date 01/28/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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