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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 K240032
Device Name Celerity Chemical Indicator for enspire 3000 CLCSPS
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Gregory Land
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Gregory Land
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received01/04/2024
Decision Date 04/17/2024
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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