Device Classification Name |
catheter, hemodialysis, implanted
|
510(k) Number |
K012562 |
Device Name |
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER |
Applicant |
MEDICAL COMPONENTS, INC. |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
FLORENCE A CAIKOSKI |
Correspondent |
MEDICAL COMPONENTS, INC. |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
FLORENCE A CAIKOSKI |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 08/08/2001 |
Decision Date | 02/08/2002 |
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
|
|
|