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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 K992884
Device Name WHEELCHAIR (MANUAL, NOT ELECTRICAL)
Applicant
Foshan Machinery & Equipment Import & Export Co.
2414 2nd St.
Fort Lee,  NJ  07024
Applicant Contact DON W KANG
Correspondent
Foshan Machinery & Equipment Import & Export Co.
2414 2nd St.
Fort Lee,  NJ  07024
Correspondent Contact DON W KANG
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/25/1999
Decision Date 11/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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