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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 K823882
Device Name M-BRACE
Applicant
Buckman Consultants
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Buckman Consultants
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3490
Classification Product Code
IPY  
Date Received12/27/1982
Decision Date 01/17/1983
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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