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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 K112591
Device Name SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS
Applicant
Safe Secure Packaging Co., Ltd.
Chengguang Industrial Park,
#4 Kukeng Po New Village
Shenzhen, Guangdon,  CN 5181100
Applicant Contact GARFIELD WANG
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact PAULA WILKERSON
Regulation Number880.6850
Classification Product Code
FRG  
Date Received09/07/2011
Decision Date 02/07/2012
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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