510(k) K161180
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2016
- Date Received
- April 27, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Container, Sharps
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type