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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 K080446
Device Name RAPIDVIT AND RAPIDWARM CLEAVE
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 Received02/19/2008
Decision Date 11/26/2008
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
Predetermined Change
Control Plan Authorized		 No
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