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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Lumbo-Sacral
510(k) Number K803033
Device Name CRUSADER HYPEREXTENSION BRACE
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
IPY  
Date Received12/01/1980
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
Predetermined Change
Control Plan Authorized		 No
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