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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 K992566
Device Name AF-150 HEMODIALYZER
Applicant
ALTHIN MEDICAL AB
FRIDHEMSVAGEN 15
RONNEBY,  SE S-37221
Applicant Contact LARS-OLOF SANDBERG
Correspondent
ALTHIN MEDICAL AB
FRIDHEMSVAGEN 15
RONNEBY,  SE S-37221
Correspondent Contact LARS-OLOF SANDBERG
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/02/1999
Decision Date 01/18/2000
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
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