Device Classification Name |
condom
|
510(k) Number |
K943880 |
Device Name |
RIA LATEX CONDOM |
Applicant |
MBF PERSONAL CARE SDN. BHD. |
PLO 22,SENAI INDUSTRIAL ESTATE |
PHASE 1 |
81400 SENAI, JOHOR,
MY
81400
|
|
Applicant Contact |
T H OOI |
Correspondent |
MBF PERSONAL CARE SDN. BHD. |
PLO 22,SENAI INDUSTRIAL ESTATE |
PHASE 1 |
81400 SENAI, JOHOR,
MY
81400
|
|
Correspondent Contact |
T H OOI |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/09/1994 |
Decision Date | 02/13/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|