Device Classification Name |
Condom With Nonoxynol-9
|
510(k) Number |
K033163 |
Device Name |
CAUTION CONDOMS |
Applicant |
RICHARD VAN HAUSSEN AMERICA, INC. |
5777 W. CENTURY BLVD. |
#1648 |
LOS ANGELES,
CA
90045
|
|
Applicant Contact |
RICHARD QUAISON |
Correspondent |
RICHARD VAN HAUSSEN AMERICA, INC. |
5777 W. CENTURY BLVD. |
#1648 |
LOS ANGELES,
CA
90045
|
|
Correspondent Contact |
RICHARD QUAISON |
Regulation Number | 884.5310
|
Classification Product Code |
|
Date Received | 11/07/2003 |
Decision Date | 04/27/2004 |
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 |
Yes
|
|
|