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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K931935
Device Name ENDPOINT 500 PERACETIC ACID TEST INDICATORS
Applicant
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Applicant Contact MARK ALDANA
Correspondent
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Correspondent Contact MARK ALDANA
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received04/19/1993
Decision Date 02/07/1994
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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