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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Traction, Non-Powered
510(k) Number K803021
Device Name UPPER EXTREMITY TRACTION DEVICE
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 Number888.5850
Classification Product Code
HST  
Date Received11/26/1980
Decision Date 12/12/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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