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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 K864573
Device Name ALT WHEELCHAIR
Applicant
Alt Design
South 3rd St.
Wood Lake,  MN  56297
Applicant Contact ALAN THOLKES
Correspondent
Alt Design
South 3rd St.
Wood Lake,  MN  56297
Correspondent Contact ALAN THOLKES
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/20/1986
Decision Date 12/16/1986
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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