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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
Vitrolife Sweden AB
Gustaf Werners gata 2
Vastra Frolunda,  SE SE-42132
Applicant Contact Anja Bengtzelius
Regulatory Specialist, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact Greg Holland
Regulation Number884.6100
Classification Product Code
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