Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K951946 |
Device Name |
HYSTEROSYS FLEXIBLE HYSTEROCOPE |
Applicant |
OVAMED CORP. |
760 SAN ALESO AVE. |
SUNNYVALE,
CA
94086
|
|
Applicant Contact |
CHRISTINE DECARIA |
Correspondent |
OVAMED CORP. |
760 SAN ALESO AVE. |
SUNNYVALE,
CA
94086
|
|
Correspondent Contact |
CHRISTINE DECARIA |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 04/26/1995 |
Decision Date | 11/20/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|