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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 K953427
Device Name CHAMPION, 3000 REBEL
Applicant
Kuschall of America
708 Via Alondra
Camarillo,  CA  93012
Applicant Contact THOMAS A VACHET
Correspondent
Kuschall of America
708 Via Alondra
Camarillo,  CA  93012
Correspondent Contact THOMAS A VACHET
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/21/1995
Decision Date 07/31/1995
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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