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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Limb Brace
510(k) Number K874502
Device Name GAIT-AID ORTHOPEDIC INSOLE
Applicant
GAIT-AID, INC.
4195 DUNDAS STREET WEST
SUITE 303, TORONTO (ETOBICOKE)
ONTARIO, CANADA,  CA M8X 1Y4
Applicant Contact DUNCAN A MACKILLOP
Correspondent
GAIT-AID, INC.
4195 DUNDAS STREET WEST
SUITE 303, TORONTO (ETOBICOKE)
ONTARIO, CANADA,  CA M8X 1Y4
Correspondent Contact DUNCAN A MACKILLOP
Regulation Number890.3475
Classification Product Code
IQI  
Date Received11/02/1987
Decision Date 11/30/1987
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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