510(k) K212544
K212544 is an FDA 510(k) premarket notification submitted by Ocuject, LLC for the device "MiniLoad Syringe". The FDA issued a decision of Substantially Equivalent on October 13, 2021. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Ocuject, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2021
- Date Received
- August 12, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type