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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 K140515
Device Name VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL
Original Applicant
STERIS Corporation
5960 heisley road
mentor,  OH  44060
Original Contact bill brodbeck
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received02/28/2014
Decision Date 07/17/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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