TROJAN EXTRA LARGE LATEX CONDOM


codes

Device Classification Name

condom

510(k) Number K001212
Device Name TROJAN EXTRA LARGE LATEX CONDOM
Original Applicant
ARMKEL, LLC.
half acre rd.
p.o. box 1001
cranbury, 
NJ 
08512

Original Contact stephen c kolakowsky
Regulation Number 884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received 04/14/2000
Decision Date 05/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Special
Reviewed by Third Party No

Combination Product

No