Device Classification Name |
Dilator, Catheter, Ureteral
|
510(k) Number |
K993840 |
Device Name |
BARD UROFORCE BALLOON DILATION CATHETER |
Applicant |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Applicant Contact |
ANGELA L BUNN |
Correspondent |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Correspondent Contact |
ANGELA L BUNN |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 11/12/1999 |
Decision Date | 01/31/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|