510(k) K212949
Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use by
Henan Nursecare Biotechnology Co., Ltd.
— Product Code MEG
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2022
- Date Received
- September 16, 2021
- Clearance Type
- Abbreviated
- 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