Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
FDA 510(k) clearance K221247 · decided 2022-11-01
Clearance details
- K-number
- K221247
- Device name
- Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
- Applicant
- Jiangsu Kangbao Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-02
- Decision date
- 2022-11-01
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Yangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.