Device Classification Name |
condom
|
510(k) Number |
K070830 |
Device Name |
MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) |
Applicant |
KAREX INDUSTRIES SDN BHD |
PTD. 7906/7907, TAMAN PONTIAN |
JAYA, BT. 34, JALAN JOHOR |
PONTIAN, JOHOR,
MY
82000
|
|
Applicant Contact |
LENG KIAN GOH |
Correspondent |
KAREX INDUSTRIES SDN BHD |
PTD. 7906/7907, TAMAN PONTIAN |
JAYA, BT. 34, JALAN JOHOR |
PONTIAN, JOHOR,
MY
82000
|
|
Correspondent Contact |
LENG KIAN GOH |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/26/2007 |
Decision Date | 05/08/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|