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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 K892523
Device Name GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
Applicant
Gambro, Inc.
460 Mclaws Cir.
Suite 200
Williamsburg,  VA  23185
Applicant Contact JEFFREY SHIDEMAN
Correspondent
Gambro, Inc.
460 Mclaws Cir.
Suite 200
Williamsburg,  VA  23185
Correspondent Contact JEFFREY SHIDEMAN
Regulation Number876.5820
Classification Product Code
FJI  
Date Received04/11/1989
Decision Date 05/11/1989
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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