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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 K872456
Device Name HEMOCOR PLUS HEMOCONCENTRATOR
Applicant
MINNTECH CORP.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55447
Applicant Contact LEROY J FISCHBACH
Correspondent
MINNTECH CORP.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55447
Correspondent Contact LEROY J FISCHBACH
Regulation Number876.5860
Classification Product Code
KDI  
Date Received06/23/1987
Decision Date 09/15/1987
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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