Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K902975 |
Device Name |
TWIN BALLOON INJECTOR |
Applicant |
ZINNANTI SURGICAL INSTRUMENTS, INC. |
21540-B PRAIRIE ST. |
CHATSWORTH,
CA
91311
|
|
Applicant Contact |
J ZINNANTI |
Correspondent |
ZINNANTI SURGICAL INSTRUMENTS, INC. |
21540-B PRAIRIE ST. |
CHATSWORTH,
CA
91311
|
|
Correspondent Contact |
J ZINNANTI |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 07/06/1990 |
Decision Date | 09/26/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|