G-MOPS G5 SERIES


Device Classification Name

media, reproductive

510(k) Number K081115
Device Name G-MOPS G5 SERIES
Applicant
VITROLIFE SWEDEN AB
faktorvagen 13
kungsbacka, 

SE

se-434 37

Applicant Contact kjell kjork
Correspondent
VITROLIFE SWEDEN AB
faktorvagen 13
kungsbacka, 

SE

se-434 37

Correspodent Contact kjell kjork
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 04/18/2008
Decision Date 09/17/2008
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

Yes