Device Classification Name |
system, dialysate delivery, central multiple patient
|
510(k) Number |
K843623 |
Device Name |
UNILYTE A |
Applicant |
MEDICAL ENTERPRISES, LTD. |
3925 WEST NORTHSIDE DR. |
JACKSON,
MS
39209
|
|
Applicant Contact |
HOLLAND |
Correspondent |
MEDICAL ENTERPRISES, LTD. |
3925 WEST NORTHSIDE DR. |
JACKSON,
MS
39209
|
|
Correspondent Contact |
HOLLAND |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 08/21/1984 |
Decision Date | 11/16/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|