Device Classification Name |
condom
|
510(k) Number |
K053367 |
Device Name |
MALE NATURAL RUBBER LATEX CONDOM |
Applicant |
INNOLATEX SDN. BHD |
PANDAMARAN INDUSTRIAL ESTATE |
PORT KLANG |
SELANGOR DARUL EHSAN,
MY
42000
|
|
Applicant Contact |
GOH MIAH KIAT |
Correspondent |
INNOLATEX SDN. BHD |
PANDAMARAN INDUSTRIAL ESTATE |
PORT KLANG |
SELANGOR DARUL EHSAN,
MY
42000
|
|
Correspondent Contact |
GOH MIAH KIAT |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/05/2005 |
Decision Date | 02/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|