510(k) K192421
K192421 is an FDA 510(k) premarket notification submitted by Flat Medical Co., Ltd. for the device "EpiFaith Syringe". The FDA issued a decision of Substantially Equivalent on Sep 27, 2019. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Flat Medical Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 27, 2019
- Date Received
- Sep 4, 2019
- 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
- 510(k)