Device Classification Name |
Catheter, Hemodialysis, Implanted
|
510(k) Number |
K042672 |
Device Name |
14F DUAL FLOATING DIALYSIS CATHETER/TRAY |
Applicant |
CARDIOMED SUPPLIES, INC. |
5 GORMLEY INDUSTRIAL AVENUE |
GORMLEY, ONTARIO,
CA
L0H 1G0
|
|
Applicant Contact |
CHRISTIAN G DUBE |
Correspondent |
CARDIOMED SUPPLIES, INC. |
5 GORMLEY INDUSTRIAL AVENUE |
GORMLEY, ONTARIO,
CA
L0H 1G0
|
|
Correspondent Contact |
CHRISTIAN G DUBE |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 09/29/2004 |
Decision Date | 03/23/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|