510(k) K173743
K173743 is an FDA 510(k) premarket notification submitted by Sang-A Frontec Co., Ltd. for the device "Greenmedi Safety Filter Syringe". The FDA issued a decision of Substantially Equivalent on Jan 28, 2019. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 28, 2019
- Date Received
- Dec 7, 2017
- 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
- 510(k)