Device Classification Name |
condom
|
510(k) Number |
K092586 |
Device Name |
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU |
Applicant |
INNOLATEX (THAILAND) LIMITED |
SOUTHERN INDUSTRIAL ESTATE |
VILLAGE 4 CHALUNG SUB-DISTRICT |
HATYAI DISTRICT, SONGKHLA,
TH
90110
|
|
Applicant Contact |
GOH SAING |
Correspondent |
INNOLATEX (THAILAND) LIMITED |
SOUTHERN INDUSTRIAL ESTATE |
VILLAGE 4 CHALUNG SUB-DISTRICT |
HATYAI DISTRICT, SONGKHLA,
TH
90110
|
|
Correspondent Contact |
GOH SAING |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/24/2009 |
Decision Date | 05/12/2010 |
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
|
|
|