510(k) K212635
K212635 is an FDA 510(k) premarket notification submitted by Hwajin Medical Co., Ltd. for the device "Sofjec". The FDA issued a decision of Substantially Equivalent on Feb 13, 2023. 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
- Feb 13, 2023
- Date Received
- Aug 19, 2021
- 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
- 510(k)