Device Classification Name |
catheter, hemodialysis, implanted
|
510(k) Number |
K051280 |
Device Name |
MEDCOMP SPLIT CATH II |
Applicant |
MEDCOMP |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
JEAN CALLOW |
Correspondent |
MEDCOMP |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
JEAN CALLOW |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 05/17/2005 |
Decision Date | 11/30/2005 |
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
|
|
|