Device Classification Name |
Catheter, Hemodialysis, Implanted
|
510(k) Number |
K113487 |
Device Name |
HEMO-CATH 10F, HEMO-CATH 12.5F |
Applicant |
MEDICAL COMPONENTS INC |
1499 DELP DRIVE |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
JEAN CALLOW |
Correspondent |
MEDICAL COMPONENTS INC |
1499 DELP DRIVE |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
JEAN CALLOW |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 11/23/2011 |
Decision Date | 03/09/2012 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|