Sterile Hypodermic Needles for Single Use
FDA 510(k) clearance K223334 · decided 2022-12-16
Clearance details
- K-number
- K223334
- Device name
- Sterile Hypodermic Needles for Single Use
- Applicant
- Zhejiang Kindly Medical Devices Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-01
- Decision date
- 2022-12-16
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wenzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.