Device Classification Name |
set, administration, for peritoneal dialysis, disposable
|
510(k) Number |
K893712 |
Device Name |
PERITONEAL DIALYSIS SYSTEM AND ACCESS. |
Applicant |
DELMED, INC. |
120 ALBANY ST. |
P.O. BOX 2623 |
NEW BRUNSWICK,
NJ
08903
|
|
Applicant Contact |
SUSAN REVELJ |
Correspondent |
DELMED, INC. |
120 ALBANY ST. |
P.O. BOX 2623 |
NEW BRUNSWICK,
NJ
08903
|
|
Correspondent Contact |
SUSAN REVELJ |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 05/18/1989 |
Decision Date | 07/24/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|