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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K883589
Device Name GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER
Applicant
Gambro, Inc.
600 Knightsbridge Pkwy.
Lincolnshire,  IL  60069
Applicant Contact R SHIDEMAN
Correspondent
Gambro, Inc.
600 Knightsbridge Pkwy.
Lincolnshire,  IL  60069
Correspondent Contact R SHIDEMAN
Regulation Number876.5820
Classification Product Code
FJI  
Date Received08/22/1988
Decision Date 09/29/1988
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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