Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K973076 |
Device Name |
EUROMEDICAL HAEMATURIA FOLEY CATHETER |
Applicant |
UNOMEDICAL SDN BHD |
POST OFFICE BOX 1108 |
ELFERS,
FL
34680
|
|
Applicant Contact |
PATRICK J LAMB |
Correspondent |
UNOMEDICAL SDN BHD |
POST OFFICE BOX 1108 |
ELFERS,
FL
34680
|
|
Correspondent Contact |
PATRICK J LAMB |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 08/18/1997 |
Decision Date | 09/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|