Device Classification Name |
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
|
510(k) Number |
K234081 |
Device Name |
RedDrop ONE (One) |
Applicant |
RedDrop Dx |
2401 Research Blvd, #206 |
Fort Collins,
CO
80526
|
|
Applicant Contact |
Kris Buchanan |
Correspondent |
RedDrop Dx |
2401 Research Blvd, #206 |
Fort Collins,
CO
80526
|
|
Correspondent Contact |
Kris Buchanan |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 12/22/2023 |
Decision Date | 03/21/2024 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|