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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Disinfectant, Medical Devices
510(k) Number K941439
Device Name RENALIN COLD STERILANT
Applicant
MINNTECH CORP.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55447
Applicant Contact MARK W ALDANA
Correspondent
MINNTECH CORP.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55447
Correspondent Contact MARK W ALDANA
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received03/24/1994
Decision Date 06/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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