510(k) K210399
K210399 is an FDA 510(k) premarket notification submitted by Owen Mumford, Ltd. for the device "Unifine SafeControl". The FDA issued a decision of Substantially Equivalent on September 17, 2021. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Owen Mumford, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2021
- Date Received
- February 10, 2021
- Clearance Type
- Special
- 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