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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 K973473
Device Name ASLI
Applicant
Texin Industrial (International) , Ltd.
169-8623 Granville St.
Vancouver, Bc,  CA V6P 5A1
Applicant Contact BILL LAM
Correspondent
Tuv Product Service, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact CAROLE STAMP
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/15/1997
Decision Date 09/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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