Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
FDA 510(k) clearance K212920 · decided 2022-03-11
Clearance details
- K-number
- K212920
- Device name
- Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
- Applicant
- Shandong Weigao Group Medical Polymer Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-14
- Decision date
- 2022-03-11
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Weihai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.