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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, limb brace
510(k) Number K802910
Device Name PLASTIC FRACTURE CAST BRACE KNEE JOINT
Applicant
ORTHOMEDICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ORTHOMEDICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.3475
Classification Product Code
IQI  
Date Received11/17/1980
Decision Date 12/22/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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