Device Classification Name |
Dialyzer, Capillary, Hollow Fiber
|
510(k) Number |
K861536 |
Device Name |
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 |
Applicant |
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
TWO VOLVO DR. |
ROCKLEIGH,
NJ
07647
|
|
Applicant Contact |
DEL DONNA |
Correspondent |
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
TWO VOLVO DR. |
ROCKLEIGH,
NJ
07647
|
|
Correspondent Contact |
DEL DONNA |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/24/1986 |
Decision Date | 07/10/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|