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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K143629
Device Name U&U Bowie-Dick Test Pack
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 Number880.2800
Classification Product Code
JOJ  
Date Received12/22/2014
Decision Date 05/19/2015
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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