Device Classification Name |
system, dialysate delivery, single patient
|
510(k) Number |
K863609 |
Device Name |
SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 |
Applicant |
INTERNATIONAL MEDICAL PRODUCTS, INC. |
4503 MOORLAND AVE. |
MINNEAPOLIS,
MN
55435
|
|
Applicant Contact |
JEFFREY SHIDEMAN,PHD |
Correspondent |
INTERNATIONAL MEDICAL PRODUCTS, INC. |
4503 MOORLAND AVE. |
MINNEAPOLIS,
MN
55435
|
|
Correspondent Contact |
JEFFREY SHIDEMAN,PHD |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 09/16/1986 |
Decision Date | 02/25/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|