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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 K251991
Device Name SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
Applicant
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
903, Tower B, Oct Central One, Mintang Rd.
Longhua District
Shenzhen City,  CN 518131
Applicant Contact Lee Parker
Correspondent
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
903, Tower B, Oct Central One, Mintang Rd.
Longhua District
Shenzhen City,  CN 518131
Correspondent Contact Lee Parker
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received06/27/2025
Decision Date 12/23/2025
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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