Device Classification Name |
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
|
510(k) Number |
K221131 |
Device Name |
Tasso+ |
Applicant |
Tasso, Inc. |
1631 15th Ave W, Suite 105 |
Seattle,
WA
98119
|
|
Applicant Contact |
Trish Kan Brown |
Correspondent |
Tasso, Inc. |
1631 15th Ave W, Suite 105 |
Seattle,
WA
98119
|
|
Correspondent Contact |
Trish Kan Brown |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 04/18/2022 |
Decision Date | 08/12/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|