Device Classification Name |
instrument, manual, specialized obstetric-gynecologic
|
510(k) Number |
K062438 |
Device Name |
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 |
Applicant |
COOK OB/GYN |
1100 WEST MORGAN STREET |
SPENCER,
IN
47460
|
|
Applicant Contact |
CINDY RUMPLE |
Correspondent |
COOK OB/GYN |
1100 WEST MORGAN STREET |
SPENCER,
IN
47460
|
|
Correspondent Contact |
CINDY RUMPLE |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 08/21/2006 |
Decision Date | 10/27/2006 |
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
|
|
|