Device Classification Name |
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
|
510(k) Number |
K131206 |
Device Name |
COOK CERVICAL RIPENING BALLOON |
Applicant |
COOK, INC. |
750 DANIELS WAY |
Blmgtn,
IN
47404
|
|
Applicant Contact |
CHIRS KILANDER |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
Blmgtn,
IN
47404
|
|
Correspondent Contact |
CHIRS KILANDER |
Regulation Number | 884.4260
|
Classification Product Code |
|
Date Received | 04/29/2013 |
Decision Date | 09/27/2013 |
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
|
|
|