Device Classification Name |
Condom
|
510(k) Number |
K012665 |
Device Name |
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT |
Applicant |
INNOLATEX SDN. BHD |
NO 16, JALAN BULAN U5/5 |
BANDAR PINGGIRAN SUBANG, |
SHAH ALAM,SELANGOR DARUL EHSAN,
MY
|
|
Applicant Contact |
CHANG AH-KAU |
Correspondent |
INNOLATEX SDN. BHD |
NO 16, JALAN BULAN U5/5 |
BANDAR PINGGIRAN SUBANG, |
SHAH ALAM,SELANGOR DARUL EHSAN,
MY
|
|
Correspondent Contact |
CHANG AH-KAU |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/13/2001 |
Decision Date | 11/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|