510(k) K140949
K140949 is an FDA 510(k) premarket notification submitted by Ultimed Incorporated for the device "ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE". The FDA issued a decision of Substantially Equivalent on Feb 9, 2015. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Ultimed Incorporated has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 9, 2015
- Date Received
- Apr 14, 2014
- 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)