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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
Applicant Contact PATRICK J MCCULLAGH
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact PATRICK J MCCULLAGH
Regulation Number880.6860
Classification Product Code
MLR  
Date Received08/07/2006
Decision Date 10/04/2007
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
Recalls CDRH Recalls
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