KOLPLUX SYSTEM


Device Classification Name

speculum, vaginal, nonmetal

510(k) Number K110766
Device Name KOLPLUX SYSTEM
Applicant
KOLPLAST CI LTDA
1468 harwell avenue
crofton, 
MD 
21114

Applicant Contact e.j. smith
Correspondent
KOLPLAST CI LTDA
1468 harwell avenue
crofton, 
MD 
21114

Correspodent Contact e.j. smith
Regulation Number 884.4530
Classification Product Code
HIB  
Date Received 03/18/2011
Decision Date 09/15/2011
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