Device Classification Name |
condom
|
510(k) Number |
K912405 |
Device Name |
LATEX PROPHYLACTIC (CONDOM) |
Applicant |
HEVEALACTICS INTL. SDN BHD |
C/O SAMSUNG AMERICA, STE 201 |
14251 E FIRESTONE BLVD |
LA MIRADA,
CA
90638
|
|
Applicant Contact |
YONG W KOO |
Correspondent |
HEVEALACTICS INTL. SDN BHD |
C/O SAMSUNG AMERICA, STE 201 |
14251 E FIRESTONE BLVD |
LA MIRADA,
CA
90638
|
|
Correspondent Contact |
YONG W KOO |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 05/30/1991 |
Decision Date | 07/21/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|