Device Classification Name |
Set, Administration, For Peritoneal Dialysis, Disposable
|
510(k) Number |
K801220 |
Device Name |
PERITONEAL DIALYSIS CYCLER SET W/PUMP |
Applicant |
AMERICAN MEDICAL PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMERICAN MEDICAL PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 05/22/1980 |
Decision Date | 08/12/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|