Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K220202 |
Device Name |
Uterine ElevatOR PRO with OccludOR Balloon |
Applicant |
The O R Company Pty Ltd |
1/32 Silkwood Rise |
Carrum Downs,
AU
3201
|
|
Applicant Contact |
Nicole Conway |
Correspondent |
The O R Company Pty Ltd |
1/32 Silkwood Rise |
Carrum Downs,
AU
3201
|
|
Correspondent Contact |
Nicole Conway |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 01/24/2022 |
Decision Date | 03/31/2022 |
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
|
|
|