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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilizer, chemical
510(K) Number K062297
Device Name VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
Applicant
STERIS CORPORATION
5960 heisley road
mentor,  OH  44060
Contact patrick j mccullagh
Regulation Number880.6860
Classification Product Code
MLR  
Date Received08/07/2006
Decision Date 10/04/2007
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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