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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 K945631
Device Name 155 SCE(TM) HEMODIALYZER
Applicant
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014 -9308
Applicant Contact MARY LANE
Correspondent
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014 -9308
Correspondent Contact MARY LANE
Regulation Number876.5820
Classification Product Code
FJI  
Date Received11/16/1994
Decision Date 05/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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