Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
510(k) Number |
K971313 |
Device Name |
NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET |
Applicant |
NATIONAL MEDICAL CARE, INC. |
2 VOLVO DR. |
ROCKLEIGH,
NJ
07647
|
|
Applicant Contact |
DEBRA L BING |
Correspondent |
NATIONAL MEDICAL CARE, INC. |
2 VOLVO DR. |
ROCKLEIGH,
NJ
07647
|
|
Correspondent Contact |
DEBRA L BING |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/09/1997 |
Decision Date | 10/27/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|