Device Classification Name |
Catheters, Salpingography
|
510(k) Number |
K931534 |
Device Name |
OVAMED INTRAUTERINE ACCESS CATHETER |
Applicant |
OVAMED CORP. |
111 WEST EVELYN AVENUE, |
SUITE 214 |
SUNNYVALE,
CA
94086
|
|
Applicant Contact |
CHRISTINE DECARIA |
Correspondent |
OVAMED CORP. |
111 WEST EVELYN AVENUE, |
SUITE 214 |
SUNNYVALE,
CA
94086
|
|
Correspondent Contact |
CHRISTINE DECARIA |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 03/29/1993 |
Decision Date | 07/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|