Device Classification Name |
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
|
510(k) Number |
K890869 |
Device Name |
BARD HYSTEROSALPINGOGRAPHY CATHETERS |
Applicant |
C.R. BARD, INC. |
5 FEDERAL ST. |
P.O. BOX 5069 |
BILLERICA,
MA
01822
|
|
Applicant Contact |
ERNEST MANFREDO |
Correspondent |
C.R. BARD, INC. |
5 FEDERAL ST. |
P.O. BOX 5069 |
BILLERICA,
MA
01822
|
|
Correspondent Contact |
ERNEST MANFREDO |
Regulation Number | 884.1300
|
Classification Product Code |
|
Date Received | 02/21/1989 |
Decision Date | 04/25/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|