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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 K992594
Device Name A-15 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 Number876.5820
Classification Product Code
FJI  
Date Received08/03/1999
Decision Date 09/24/1999
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
Predetermined Change
Control Plan Authorized		 No
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