510(k) K152808
K152808 is an FDA 510(k) premarket notification submitted by U&U Medical Technology Co, Ltd. for the device "U&U Insulin Syringe with/without Safety Retractable Device". The FDA issued a decision of Substantially Equivalent on Mar 25, 2016. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. U&U Medical Technology Co, Ltd. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 25, 2016
- Date Received
- Sep 28, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Antistick
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)