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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 K102217
FOIA Releasable 510(k) K102217
Device Name SYSTEM 1E CHEMICAL INDICATOR
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact ROBERT F SULLIVAN
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact ROBERT F SULLIVAN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received08/06/2010
Decision Date 11/22/2010
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
Predetermined Change
Control Plan Authorized		 No
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