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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K913483
Device Name MINNILERT(R) PRESSURE MONITOR
Applicant
Minntech Corp.
14605 28th Ave. N.
Minneapolis,  MN  55447
Applicant Contact LEROY J FISCHBACH
Correspondent
Minntech Corp.
14605 28th Ave. N.
Minneapolis,  MN  55447
Correspondent Contact LEROY J FISCHBACH
Regulation Number876.5820
Classification Product Code
KOC  
Date Received08/06/1991
Decision Date 09/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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