Device Classification Name |
system, peritoneal, automatic delivery
|
510(k) Number |
K902149 |
FOIA Releasable 510(k) |
K902149
|
Device Name |
FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM |
Applicant |
FRESENIUS/DELMED, INC. |
4090 PIKE LN. |
CONCORD,
CA
94520
|
|
Applicant Contact |
THOMAS E CANE |
Correspondent |
FRESENIUS/DELMED, INC. |
4090 PIKE LN. |
CONCORD,
CA
94520
|
|
Correspondent Contact |
THOMAS E CANE |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 05/15/1990 |
Decision Date | 10/30/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|