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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 K180139
Device Name Safe Secure Sterilization Pouches and Rolls
Applicant
Safe Secure Packing Co., Ltd.
Yaoshan Industrial Park
Xiegang Town
Dongguan City,  CN 523601
Applicant Contact Howard Jia
Correspondent
Safe Secure Packing Co., Ltd.
Yaoshan Industrial Park
Xiegang Town
Dongguan City,  CN 523601
Correspondent Contact Howard Jia
Regulation Number880.6850
Classification Product Code
FRG  
Date Received01/18/2018
Decision Date 01/03/2019
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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