NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six
FDA 510(k) clearance K152340 · decided 2016-05-31
Clearance details
- K-number
- K152340
- Device name
- NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six
- Applicant
- North American Rescue, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-08-19
- Decision date
- 2016-05-31
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Greer, SC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.