Device Classification Name |
set, tubing, blood, with and without anti-regurgitation valve
|
510(k) Number |
K853962 |
Device Name |
ERIKA ARTERIAL LINE 03-9837-0 |
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 | 09/25/1985 |
Decision Date | 10/18/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|