Device Classification Name |
condom
|
510(k) Number |
K896098 |
Device Name |
GUARDIAN & JANITEX CONDOM/PROPHYLACTIC |
Applicant |
ALLIED RUBBER INDUSTRIES SDN. BHD. |
2009, KAWASAN MIEL |
LOT 2, JALAN BEREMBAN 15/12, |
400000 SHAH ALAM.MALAYSIA,
MY
|
|
Applicant Contact |
TONG |
Correspondent |
ALLIED RUBBER INDUSTRIES SDN. BHD. |
2009, KAWASAN MIEL |
LOT 2, JALAN BEREMBAN 15/12, |
400000 SHAH ALAM.MALAYSIA,
MY
|
|
Correspondent Contact |
TONG |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 10/20/1989 |
Decision Date | 12/19/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|