510(k) K152339
K152339 is an FDA 510(k) premarket notification submitted by Owen Mumford, Ltd. for the device "Unifine Pentips/ Unifine Pentips Plus". The FDA issued a decision of Substantially Equivalent on June 24, 2016. 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
- June 24, 2016
- Date Received
- August 19, 2015
- 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