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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K904913
Device Name HANDI-TRAK WHEELCHAIR SNOW CHAINS
Applicant
Handi-Trak, Inc.
1521 S. 85th St.
West Allis,  WI  53214
Applicant Contact RANDY D GENAW
Correspondent
Handi-Trak, Inc.
1521 S. 85th St.
West Allis,  WI  53214
Correspondent Contact RANDY D GENAW
Regulation Number890.3920
Classification Product Code
KNN  
Date Received10/31/1990
Decision Date 11/07/1990
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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