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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Cervical-Thoracic, Rigid
510(k) Number K832741
Device Name JASON CERVICAL ORTHOSIS
Applicant
Orthomedics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Orthomedics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3490
Classification Product Code
IQF  
Date Received08/15/1983
Decision Date 09/20/1983
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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