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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TASSO+ 90816204 not registered Live/Pending |
TASSO INC. 2021-07-07 |