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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 K001156
Device Name PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
Applicant
GAMBRO RENAL PRODUCTS
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Applicant Contact BENITA BRADFORD
Correspondent
GAMBRO RENAL PRODUCTS
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Correspondent Contact BENITA BRADFORD
Regulation Number876.5860
Classification Product Code
KDI  
Date Received04/10/2000
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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