Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K192278 |
Device Name |
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) |
Applicant |
UVision360 Inc. |
158 Wind Chime Ct. Ste. 201 |
Raleigh,
NC
27615
|
|
Applicant Contact |
Allison London Brown |
Correspondent |
MethodSense, Inc. |
1 Copley Pkwy, Ste. 410 |
Morrisville,
NC
27560
|
|
Correspondent Contact |
Rita King |
Regulation Number | 884.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/22/2019 |
Decision Date | 11/01/2019 |
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
|
|
|