NeedleSmart Professional (NS Pro)
FDA 510(k) clearance K202073 · decided 2021-03-25
Clearance details
- K-number
- K202073
- Device name
- NeedleSmart Professional (NS Pro)
- Applicant
- Needlesmart Limited
- Decision
- Substantially Equivalent
- Date received
- 2020-07-27
- Decision date
- 2021-03-25
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- MTV
- Device class
- 2
- Regulation number
- 880.6210
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Knowsley, Prescot, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.