Device Classification Name |
pessary, vaginal
|
510(k) Number |
K883721 |
Device Name |
FEMALE CONTINENCE DEVICE |
Applicant |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Applicant Contact |
DEXTER J ELKINS |
Correspondent |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
DEXTER J ELKINS |
Regulation Number | 884.3575
|
Classification Product Code |
|
Date Received | 08/31/1988 |
Decision Date | 10/03/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|