Device Classification Name |
Set, Administration, For Peritoneal Dialysis, Disposable
|
510(k) Number |
K871155 |
Device Name |
DELFLEX RIGID DRAIN CONTAINER |
Applicant |
DELMED, INC. |
P.O. DRAWER 190 |
FREEHOLD,
NJ
07728
|
|
Applicant Contact |
DOERSCHUK, PHD |
Correspondent |
DELMED, INC. |
P.O. DRAWER 190 |
FREEHOLD,
NJ
07728
|
|
Correspondent Contact |
DOERSCHUK, PHD |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 03/24/1987 |
Decision Date | 07/16/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|