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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K032431
Device Name PRISMA M60/M100 SETS
Applicant
GAMBRO, INC.
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Applicant Contact ROD J RYLANDS
Correspondent
GAMBRO, INC.
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Correspondent Contact ROD J RYLANDS
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/06/2003
Decision Date 09/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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