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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 K123162
Device Name U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL
Applicant
U&U Medical Technology Co, Ltd.
Dongzhou Village, Hengshanqiao
Changzhou,  CN 213119
Applicant Contact GARFIELD WANG
Correspondent
U&U Medical Technology Co, Ltd.
Dongzhou Village, Hengshanqiao
Changzhou,  CN 213119
Correspondent Contact GARFIELD WANG
Regulation Number880.6850
Classification Product Code
FRG  
Date Received10/09/2012
Decision Date 02/26/2014
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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