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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 K170560
Device Name SAGE Vitrification Kit and SAGE Vitrification Warming Kit
CooperSurgical Inc
95 Corporate Drive
Trumbull,  CT  06611
Applicant Contact Tove Kjær
Origio A/S
Knardrupvej 2
Malov,  DK 2760
Correspondent Contact Tove Kjær
Regulation Number884.6180
Classification Product Code
Date Received02/27/2017
Decision Date 04/04/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No