510(k) K133059
K133059 is an FDA 510(k) premarket notification submitted by Wenzhou Beipu Science & Technology Co., Ltd. for the device "INSULIN PEN NEEDLE". The FDA issued a decision of Substantially Equivalent on Feb 25, 2014. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 25, 2014
- Date Received
- Sep 27, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
- 510(k)