510(k) K150333
K150333 is an FDA 510(k) premarket notification submitted by Medsource International, LLC for the device "MedSource Sharps Dart". The FDA issued a decision of Substantially Equivalent on May 8, 2015. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Medsource International, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2015
- Date Received
- February 10, 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