TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT


Device Classification Name

condom

510(k) Number K073016
Device Name TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
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
HIS  
Date Received 10/25/2007
Decision Date 11/09/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No