Device Classification Name |
Catheter, Peritoneal, Long-Term Indwelling
|
510(k) Number |
K915490 |
Device Name |
MEDCOMP PERITONEAL DIALYSIS CATHETERS |
Applicant |
MEDICAL COMPONENTS, INC. |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
ANN EMELE |
Correspondent |
MEDICAL COMPONENTS, INC. |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
ANN EMELE |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 12/06/1991 |
Decision Date | 02/02/1994 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|