Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K903777 |
Device Name |
WRP FOLEYCATH |
Applicant |
WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
PERU BANDAR BARU SALAK TINGGI |
43900 SEPANG |
SELANGOR, MALAYSIA,
MY
|
|
Applicant Contact |
ENG KEAT |
Correspondent |
WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
PERU BANDAR BARU SALAK TINGGI |
43900 SEPANG |
SELANGOR, MALAYSIA,
MY
|
|
Correspondent Contact |
ENG KEAT |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 08/20/1990 |
Decision Date | 12/13/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|