The following data is part of a premarket notification filed by Qlicksmart Pty Ltd. with the FDA for Qlicksmart Bladeflask Universal.
| Device ID | K213274 |
| 510k Number | K213274 |
| Device Name: | Qlicksmart BladeFlask UNIVERSAL |
| Classification | Container, Sharps |
| Applicant | Qlicksmart Pty Ltd. Level 1, 148 Boundary Street, West End Brisbane, AU 4101 |
| Contact | Michael Sinnott |
| Correspondent | Carlos Castellanos Qlicksmart Pty Ltd. Level 1, 148 Boundary Street, West End Brisbane, AU 4101 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 29337363001845 | K213274 | 000 |
| 29337363001838 | K213274 | 000 |