TROJAN-ENZ BRAND

Device Classification Name

condom

510(k) Number K071313
Device Name TROJAN-ENZ BRAND
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 05/10/2007
Decision Date 10/26/2007
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