Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K933981 |
Device Name |
CERVICAL CATHETER |
Applicant |
CONCEPTUS, INC. |
1021 HOWARD AVE. |
SAN CARLOS,
CA
94070
|
|
Applicant Contact |
ALEXIS BALL |
Correspondent |
CONCEPTUS, INC. |
1021 HOWARD AVE. |
SAN CARLOS,
CA
94070
|
|
Correspondent Contact |
ALEXIS BALL |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 08/16/1993 |
Decision Date | 12/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|