510(k) K152340
K152340 is an FDA 510(k) premarket notification submitted by North American Rescue, LLC for the device "NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six". The FDA issued a decision of Substantially Equivalent on May 31, 2016. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2016
- Date Received
- August 19, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Sharps
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type