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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, central multiple patient
510(k) Number K830908
Device Name BICARBONATE/VARIABLE SODIUM KIT-DM-367
Applicant
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received03/21/1983
Decision Date 06/08/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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