Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K232464 |
Device Name |
VereSee Optical Veres Needle System |
Applicant |
Freyja Healthcare, LLC |
488 Pleasant Street |
North Andover,
MA
01845
|
|
Applicant Contact |
Ronald Adams |
Correspondent |
Brauer Device Consultants, LLC |
7 Trail House Court |
Rockville,
MD
20850
|
|
Correspondent Contact |
Christine Brauer, PhD |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 08/15/2023 |
Decision Date | 05/02/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|