510(k) K152340

NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six by North American Rescue, LLC — Product Code MMK

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