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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Assisted Reproduction
510(k) Number K082727
Device Name FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
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 Number884.6100
Classification Product Code
MQE  
Date Received09/17/2008
Decision Date 02/06/2009
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
Predetermined Change
Control Plan Authorized		 No
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