Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K190827 |
Device Name |
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid |
Applicant |
UVision360 Inc. |
158 Wind Chime Ct. Ste. 201 |
Raleigh,
NC
27615
|
|
Applicant Contact |
Allison London Brown |
Correspondent |
MethodSense, Inc. |
1 Copley Pkwy, Suite 410 |
Morrisville,
NC
27560
|
|
Correspondent Contact |
Rita King |
Regulation Number | 884.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/01/2019 |
Decision Date | 06/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|