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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Perfusion, Kidney
510(k) Number K830994
Device Name REDOX CONTROLLER
Applicant
St. Louis Univ. Medical Center
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
St. Louis Univ. Medical Center
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5880
Classification Product Code
KDN  
Date Received03/29/1983
Decision Date 05/27/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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