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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Joint, Knee, External Brace
510(k) Number K780892
Device Name FRACTURE BRACING
Applicant
Hosmer Dorrance Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hosmer Dorrance Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3475
Classification Product Code
ITQ  
Date Received05/31/1978
Decision Date 06/13/1978
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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