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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Thoracic
510(k) Number K811750
Device Name MULTITUBULAR THORACIC AIR SPLINTS
Applicant
Roger Cestac & Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Roger Cestac & Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3490
Classification Product Code
IPT  
Date Received06/22/1981
Decision Date 07/20/1981
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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