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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 K894770
Device Name PERSONAL BACK WITH FIP KIT
Applicant
Canadian Posture and Seating Centre, Inc.
15 Howard Pl., P.O. Box 1473
Station C, Kitchener, Ontario
Canada N2g 4p2,  CA
Applicant Contact MUNDY. P ENG.
Correspondent
Canadian Posture and Seating Centre, Inc.
15 Howard Pl., P.O. Box 1473
Station C, Kitchener, Ontario
Canada N2g 4p2,  CA
Correspondent Contact MUNDY. P ENG.
Regulation Number890.3920
Classification Product Code
KNN  
Date Received07/26/1989
Decision Date 09/11/1989
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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