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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 K841368
Device Name HYPERBARIC OXYGEN GURNEY-
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 Received04/03/1984
Decision Date 05/16/1984
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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