Device Classification Name |
Condom
|
510(k) Number |
K895091 |
Device Name |
RIA (CONDOM) |
Applicant |
LA TECHNOLOGY SDN. BHD. |
PLO 22,SENAI INDUSTRIAL ESTATE |
PHASE 1 |
81400 SENAI, JOHOR,
MY
81400
|
|
Applicant Contact |
LOGANATHAN |
Correspondent |
LA TECHNOLOGY SDN. BHD. |
PLO 22,SENAI INDUSTRIAL ESTATE |
PHASE 1 |
81400 SENAI, JOHOR,
MY
81400
|
|
Correspondent Contact |
LOGANATHAN |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/08/1989 |
Decision Date | 01/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|