Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K233185 |
Device Name |
MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System |
Applicant |
C2DX, Inc. |
555 E Eliza St |
Schoolcraft,
MI
49087
|
|
Applicant Contact |
Brad Beale |
Correspondent |
C2DX, Inc. |
555 E Eliza St |
Schoolcraft,
MI
49087
|
|
Correspondent Contact |
Brad Beale |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/28/2023 |
Decision Date | 10/24/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|