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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 K172050
Device Name Follicle Aspiration Set, Reduced Single Lumen
Applicant
Vitrolife Sweden AB
Gustaf Werners Gata 2
Västra Frölunda,  SE SE-42132
Applicant Contact Anja Bengtzelius
Correspondent
Regulatory Specialist, Inc.
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact Greg Holland
Regulation Number884.6100
Classification Product Code
MQE  
Date Received07/06/2017
Decision Date 11/21/2017
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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