The following data is part of a premarket notification filed by Dongguan Microview Medical Technology Co., Ltd with the FDA for Disposable Endoscopic Cannula.
Device ID | K140213 |
510k Number | K140213 |
Device Name: | DISPOSABLE ENDOSCOPIC CANNULA |
Classification | Cannula, Suction, Uterine |
Applicant | DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD R15-08, EAST BLDG, YIHAI PLAZA CHUANGYE ROAD, NANSHAN DISTRICT Shenzhen, Guangdong, CN 518054 |
Contact | Long Yang |
Correspondent | Long Yang DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD R15-08, EAST BLDG, YIHAI PLAZA CHUANGYE ROAD, NANSHAN DISTRICT Shenzhen, Guangdong, CN 518054 |
Product Code | HGH |
CFR Regulation Number | 884.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-28 |
Decision Date | 2015-03-25 |
Summary: | summary |