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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 K120435
Device Name BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR
Original Applicant
STERIS Corporation
5960 heisley road
mentor,  OH  44060
Original Contact bill brodbeck
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received02/13/2012
Decision Date 06/04/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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