The following data is part of a premarket notification filed by Tasso, Inc. with the FDA for Tasso+.
| Device ID | K221131 |
| 510k Number | K221131 |
| Device Name: | Tasso+ |
| Classification | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Applicant | Tasso, Inc. 1631 15th Ave W, Suite 105 Seattle, WA 98119 |
| Contact | Trish Kan Brown |
| Correspondent | Trish Kan Brown Tasso, Inc. 1631 15th Ave W, Suite 105 Seattle, WA 98119 |
| Product Code | FMK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-18 |
| Decision Date | 2022-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850038691001 | K221131 | 000 |
| 00850038691134 | K221131 | 000 |
| 10850038691148 | K221131 | 000 |
| 10850038691155 | K221131 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TASSO+ 90816204 not registered Live/Pending |
TASSO INC. 2021-07-07 |