Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K142164 |
Device Name |
MANIPULATOR; MANIPULATOR PRO |
Applicant |
GYNETECH PTY. LTD. |
229 MARVILLA CIRCLE |
PACIFICA,
CA
94044
|
|
Applicant Contact |
KEVIN MACDONALD |
Correspondent |
GYNETECH PTY. LTD. |
229 MARVILLA CIRCLE |
PACIFICA,
CA
94044
|
|
Correspondent Contact |
KEVIN MACDONALD |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 08/06/2014 |
Decision Date | 12/17/2014 |
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
|
|
|