510(k) K231907
K231907 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Medline Safety Insulin and TB Syringes". The FDA issued a decision of Substantially Equivalent on October 18, 2023. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Medline Industries, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2023
- Date Received
- June 29, 2023
- 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