Device Classification Name |
Condom With Nonoxynol-9
|
510(k) Number |
K010178 |
Device Name |
SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
Applicant |
INNOLATEX SDN. BHD |
NO. 16, JALAN BULAN U5/5, |
BANDAR PINGGIRAN SUBANG |
SHAH ALAM, SELANGOR D.E.,
MY
40150
|
|
Applicant Contact |
CHANG AU-KAU |
Correspondent |
INNOLATEX SDN. BHD |
NO. 16, JALAN BULAN U5/5, |
BANDAR PINGGIRAN SUBANG |
SHAH ALAM, SELANGOR D.E.,
MY
40150
|
|
Correspondent Contact |
CHANG AU-KAU |
Regulation Number | 884.5310
|
Classification Product Code |
|
Date Received | 01/19/2001 |
Decision Date | 04/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|