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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Air Bubble
510(k) Number K904992
Device Name MINNILERT AIR DETECTOR
Applicant
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Applicant Contact LEROY J FISCHBACH
Correspondent
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Correspondent Contact LEROY J FISCHBACH
Regulation Number876.5820
Classification Product Code
FJF  
Date Received11/07/1990
Decision Date 02/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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