KDL SYRINGES AND NEEDLE
FDA 510(k) clearance K112057 · decided 2011-12-14
Clearance details
- K-number
- K112057
- Device name
- KDL SYRINGES AND NEEDLE
- Applicant
- Shanghai Kindly Enterprise Dev. Group Co.,
- Decision
- Substantially Equivalent
- Date received
- 2011-07-19
- Decision date
- 2011-12-14
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.