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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 K910974
Device Name MCCONNELL SHOULDER BRACE
Applicant
Mcconnell Orthopedic
Treee Lincoln Centre
5430 Lbj Fwy. Suite 1540
Dallas,  TX  75240
Applicant Contact DENNIS T GRIGGS
Correspondent
Mcconnell Orthopedic
Treee Lincoln Centre
5430 Lbj Fwy. Suite 1540
Dallas,  TX  75240
Correspondent Contact DENNIS T GRIGGS
Regulation Number890.3475
Classification Product Code
IQI  
Date Received03/07/1991
Decision Date 03/21/1991
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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