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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 K153540
Device Name Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
Applicant
Safe Secure Packaging Co., Ltd.
#4 Chengguang Industrial Park
Gunlan St., Baoan District
Shenzhen,  CN 518100
Applicant Contact HOWARD JIA
Correspondent
Namsa
4050 Olson Memorial Highway
Golden Valley,  MN  55422
Correspondent Contact BRIAN EDWARDS
Regulation Number880.6850
Classification Product Code
FRG  
Date Received12/10/2015
Decision Date 08/04/2016
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
Recalls CDRH Recalls
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