510(k) K152350
K152350 is an FDA 510(k) premarket notification submitted by Ningbo Feite Medical Device Co., Ltd. for the device "Regular and Special Umbilical Cord Clamp and Cutter". The FDA issued a decision of Substantially Equivalent on June 28, 2016. The device falls under product code NBZ (Clamp And Cutter, Umbilical), a Class II device regulated under 21 CFR 884.4530.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2016
- Date Received
- August 20, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp And Cutter, Umbilical
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type