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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 K881270
Device Name GAMBRO MULTIPURPOSE SYSTEM MPS-10
Applicant
Gambro, Inc.
600 Knightsbridge Pkwy.
Lincolnshire,  IL  60069
Applicant Contact JEFFREY SHIDEMAN,PHD
Correspondent
Gambro, Inc.
600 Knightsbridge Pkwy.
Lincolnshire,  IL  60069
Correspondent Contact JEFFREY SHIDEMAN,PHD
Regulation Number876.5860
Classification Product Code
FII  
Date Received03/24/1988
Decision Date 08/24/1988
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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