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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K242839
Device Name Safe Secure Sterilization Pouches and Rolls
Applicant
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
6a01, Block 1, Ahoke Plaza, Daling Community
Minzhi St., Longhua District
Shenzhen,  CN 518109
Applicant Contact Parker Lee
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received09/19/2024
Decision Date 10/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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