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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name component, cast
510(k) Number K823394
Device Name WALKING HEEL
Original Applicant
ORTHOPEDIC SYSTEMS, INC.
Regulation Number888.5940
Classification Product Code
LGF  
Date Received11/12/1982
Decision Date 12/03/1982
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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