Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K932115 |
Device Name |
ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI |
Applicant |
BLAIRDEN PRECISION INSTRUMENTS, INC. |
10053 LAKEVIEW AVE. |
LENEXA,
KS
66219
|
|
Applicant Contact |
JIM ROWDEN |
Correspondent |
BLAIRDEN PRECISION INSTRUMENTS, INC. |
10053 LAKEVIEW AVE. |
LENEXA,
KS
66219
|
|
Correspondent Contact |
JIM ROWDEN |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 05/03/1993 |
Decision Date | 06/24/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|