510(k) K252033
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2025
- Date Received
- June 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type