CAUTION CONDOMS

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

Correspodent Contact richard quaison
Regulation Number 884.5310
Classification Product Code
LTZ  
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