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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 K954987
Device Name ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
Applicant
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
13520 S.E. PHEASANT COURT
PORTLAND,  OR  97222 -1298
Applicant Contact ALAN LEWIS
Correspondent
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
13520 S.E. PHEASANT COURT
PORTLAND,  OR  97222 -1298
Correspondent Contact ALAN LEWIS
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/31/1995
Decision Date 08/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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