Device Classification Name |
set, administration, for peritoneal dialysis, disposable
|
510(k) Number |
K900005 |
Device Name |
DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1 |
Applicant |
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
TWO VOLVO DR. |
ROCKLEIGH,
NJ
07647
|
|
Applicant Contact |
JOHN R TREMBLEY |
Correspondent |
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
TWO VOLVO DR. |
ROCKLEIGH,
NJ
07647
|
|
Correspondent Contact |
JOHN R TREMBLEY |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 01/02/1990 |
Decision Date | 03/02/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|