510(k) K140213
K140213 is an FDA 510(k) premarket notification submitted by Dongguan Microview Medical Technology Co., Ltd. for the device "DISPOSABLE ENDOSCOPIC CANNULA". The FDA issued a decision of Substantially Equivalent on March 25, 2015. The device falls under product code HGH (Cannula, Suction, Uterine), a Class II device regulated under 21 CFR 884.5070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2015
- Date Received
- January 28, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Suction, Uterine
- Device Class
- Class II
- Regulation Number
- 884.5070
- Review Panel
- OB
- Submission Type