510(k) K213077
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2022
- Date Received
- September 23, 2021
- 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