TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM


Device Classification Name

condom, synthetic

510(k) Number K050828
Device Name TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
Applicant
CHURCH & DWIGHT CO., INC.
469 north harrison street
princeton, 
NJ 
08543

Applicant Contact stephen c kolakowsky
Correspondent
CHURCH & DWIGHT CO., INC.
469 north harrison street
princeton, 
NJ 
08543

Correspodent Contact stephen c kolakowsky
Regulation Number 884.5300
Classification Product Code
MOL  
Date Received 04/01/2005
Decision Date 02/28/2006
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No