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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 K802555
Device Name COTTRELL 90/90 BACKTRAC
Applicant
LOSSING ORTHOPEDIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LOSSING ORTHOPEDIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.5850
Classification Product Code
HST  
Date Received10/16/1980
Decision Date 10/31/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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