U&U STERILE HYPODERMIC NEEDLE
FDA 510(k) clearance K132552 · decided 2013-11-13
Clearance details
- K-number
- K132552
- Device name
- U&U STERILE HYPODERMIC NEEDLE
- Applicant
- U&U Medical Technology Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-14
- Decision date
- 2013-11-13
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Changzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.