Device Classification Name |
Instrument, Manual, Specialized Obstetric-Gynecologic
|
510(k) Number |
K013597 |
Device Name |
TAMPONADE UTERINE BALLOON CATHETER SET |
Applicant |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Applicant Contact |
CINDY RUMPLE |
Correspondent |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
CINDY RUMPLE |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 10/31/2001 |
Decision Date | 04/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|