Device Classification Name |
kit, repair, catheter, hemodialysis
|
510(k) Number |
K011015 |
Device Name |
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 |
Applicant |
C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
PEGGY KEIFFER |
Correspondent |
C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
PEGGY KEIFFER |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 04/04/2001 |
Decision Date | 06/22/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|