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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, External, Limb, Ankle/Foot
510(k) Number K823396
Device Name FREE FLEX HEEL HEIGHT ADJUSTOR
Applicant
ORTHOPEDIC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ORTHOPEDIC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.3420
Classification Product Code
ISH  
Date Received11/12/1982
Decision Date 11/29/1982
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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