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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 K173731
Device Name SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
Applicant
CooperSurgical, Inc
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact Tove Kjaer
Correspondent
Origio a/s
Knardrupvej 2
Malov,  DK 06611
Correspondent Contact Tove Kjaer
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/06/2017
Decision Date 03/02/2018
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
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