LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT


Device Classification Name

condom

510(k) Number K030176
Device Name LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT
Original Applicant
SURETEX, LTD.
1500 industrial rd.
p.o. box 1252
dothan, 
AL 
36302

Original Contact cynthia a ingram
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 01/17/2003
Decision Date 04/17/2003
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