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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 K894422
Device Name TUFFCARE MEDICAL PRODUCTS WHEELCHAIR
Applicant
Tuffman Industries
3558 E. Ent. Dr.
Anaheim,  CA  92807
Applicant Contact CALVIN CHANG
Correspondent
Tuffman Industries
3558 E. Ent. Dr.
Anaheim,  CA  92807
Correspondent Contact CALVIN CHANG
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/17/1989
Decision Date 08/03/1989
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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