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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name labware, assisted reproduction
510(k) Number K181461
Device Name Rapid-i™ Kit
Vitrolife Sweden AB
Gustaf Werners gata 2
Vastra Frolunda,  SE 421 32
Applicant Contact Nina Arvidsson
Vitrolife Sweden AB
Gustaf Werners gata 2
SE-421 32 Vastra Frolunda,  SE
Correspondent Contact Nina Arvidsson
Regulation Number884.6160
Classification Product Code
Date Received06/04/2018
Decision Date 01/04/2019
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