Device Classification Name |
catheter, peritoneal dialysis, single use
|
510(k) Number |
K860155 |
Device Name |
PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 |
Applicant |
MEDICAL COMPONENTS, INC. |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
MICHEAL I BASTA |
Correspondent |
MEDICAL COMPONENTS, INC. |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
MICHEAL I BASTA |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 01/16/1986 |
Decision Date | 02/14/1986 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|