Device Classification Name |
catheters, salpingography
|
510(k) Number |
K931476 |
Device Name |
NOVY CORNUAL CANNULATION SET |
Applicant |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Applicant Contact |
DEXTER ELKINS |
Correspondent |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
DEXTER ELKINS |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 03/24/1993 |
Decision Date | 07/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|