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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
510(k) Number K990010
Device Name ALTHIN MEDICAL AB ALTRACART II
Applicant
Althin Medical AB
Box 39, (Fridhemsv. 15)
372 21 Ronneby,  SE 372 21
Applicant Contact ULF LUNDGREN
Correspondent
Althin Medical AB
Box 39, (Fridhemsv. 15)
372 21 Ronneby,  SE 372 21
Correspondent Contact ULF LUNDGREN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received01/04/1999
Decision Date 04/15/1999
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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