Device Classification Name |
Surgeon'S Gloves
|
510(k) Number |
K935464 |
Device Name |
COMFIT |
Applicant |
WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
PERU BANDAR BARU SALAK TINGGI |
43900 SEPANG |
SELANGOR, MALAYSIA,
MY
|
|
Applicant Contact |
ONG GHEE CHEE |
Correspondent |
WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
PERU BANDAR BARU SALAK TINGGI |
43900 SEPANG |
SELANGOR, MALAYSIA,
MY
|
|
Correspondent Contact |
ONG GHEE CHEE |
Regulation Number | 878.4460 |
Classification Product Code |
|
Date Received | 11/12/1993 |
Decision Date | 05/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|