510(k) K250733
K250733 is an FDA 510(k) premarket notification submitted by Bimed Teknik Aletler Sanayi & Ticaret A.S. for the device "3DOSE 1ml Syringe". The FDA issued a decision of Substantially Equivalent on July 3, 2025. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2025
- Date Received
- March 11, 2025
- Clearance Type
- Traditional
- 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