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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 K962309
Device Name ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
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 Received06/17/1996
Decision Date 12/27/1996
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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