Safe Block Pen Needle
FDA 510(k) clearance K151311 · decided 2016-02-10
Clearance details
- K-number
- K151311
- Device name
- Safe Block Pen Needle
- Applicant
- Artsana S.P.A
- Decision
- Substantially Equivalent
- Date received
- 2015-05-18
- Decision date
- 2016-02-10
- Days to decision
- 268 days
- Clearance type
- Abbreviated
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Grandate, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.