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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 K854497
Device Name VOYAGEUR, BUTTERFLY ONE, CADET LAURENTIAN, HORIZON
Applicant
Canadian Wheelchair
1360 Blundell Rd.
Mississauga,Ontario,  CA
Applicant Contact STUART HODGINS
Correspondent
Canadian Wheelchair
1360 Blundell Rd.
Mississauga,Ontario,  CA
Correspondent Contact STUART HODGINS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/12/1985
Decision Date 12/02/1985
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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