Device Classification Name |
cup, menstrual
|
510(k) Number |
K910254 |
Device Name |
DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) |
Applicant |
COOPERSURGICAL, INC. |
C/O CHARLES I. ROSE & CO., INC |
1963 ROCK STREET, SUITE #17 |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
CHARLES L ROSE |
Correspondent |
COOPERSURGICAL, INC. |
C/O CHARLES I. ROSE & CO., INC |
1963 ROCK STREET, SUITE #17 |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
CHARLES L ROSE |
Regulation Number | 884.5400
|
Classification Product Code |
|
Date Received | 01/22/1991 |
Decision Date | 04/18/1991 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|