Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K993892 |
Device Name |
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45 |
Applicant |
C.R. BARD, INC. |
129 CONCORD RD., BLDG. #3 |
BILLERICA,
MA
01821
|
|
Applicant Contact |
MARION GORDON |
Correspondent |
C.R. BARD, INC. |
129 CONCORD RD., BLDG. #3 |
BILLERICA,
MA
01821
|
|
Correspondent Contact |
MARION GORDON |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/16/1999 |
Decision Date | 01/06/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|