Device Classification Name |
Catheter, Ureteral, Gastro-Urology
|
510(k) Number |
K032521 |
Device Name |
BARD DUAL LUMEN URETERAL CATHETER |
Applicant |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Applicant Contact |
FRANCES HARRISON |
Correspondent |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Correspondent Contact |
FRANCES HARRISON |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 08/15/2003 |
Decision Date | 11/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|