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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Suction, Uterine
510(k) Number K140213
Device Name DISPOSABLE ENDOSCOPIC CANNULA
Applicant
Dongguan Microview Medical Technology Co., Ltd.
R15-08, E. Bldg, Yihai Plz.
Chuangye Rd., Nanshan District
Shenzhen, Guangdong,  CN 518054
Applicant Contact LONG YANG
Correspondent
Dongguan Microview Medical Technology Co., Ltd.
R15-08, E. Bldg, Yihai Plz.
Chuangye Rd., Nanshan District
Shenzhen, Guangdong,  CN 518054
Correspondent Contact LONG YANG
Regulation Number884.5070
Classification Product Code
HGH  
Date Received01/28/2014
Decision Date 03/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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