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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Sealed
510(k) Number K822386
Device Name COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA
Applicant
Hospal Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hospal Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5860
Classification Product Code
FII  
Date Received08/09/1982
Decision Date 10/06/1982
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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