CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,


Device Classification Name

condom

510(k) Number K021186
Device Name CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,
Original Applicant
CONDOMI ERFERT PRODOKTIONSGESELLSCHAFT MBH
55 northern blvd. suite 200
great neck, 
NY 
11021

Original Contact carolann kotula
Regulation Number 884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received 04/15/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No