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
FDA 510(k) clearance K212949 · decided 2022-02-24
Clearance details
- K-number
- K212949
- Device name
- 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
- Applicant
- Henan Nursecare Biotechnology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-16
- Decision date
- 2022-02-24
- Days to decision
- 161 days
- Clearance type
- Abbreviated
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Xinxiang, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.