TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT


codes

Device Classification Name

condom

510(k) Number K000748
Device Name TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
Original Applicant
ARMKEL, LLC.
p.o. box 1001, half acre rd.
cranbury, 
NJ 
08512

Original Contact stephen c kolakowsky
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 03/08/2000
Decision Date 04/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Special
Reviewed by Third Party No

Combination Product

No