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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact KJELL KJORK
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/18/2008
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
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