510(k) K213274
K213274 is an FDA 510(k) premarket notification submitted by Qlicksmart Pty , Ltd. for the device "Qlicksmart BladeFlask UNIVERSAL". The FDA issued a decision of Substantially Equivalent on June 22, 2022. 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
- June 22, 2022
- Date Received
- September 30, 2021
- Clearance Type
- Abbreviated
- 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