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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
Applicant
Coopersurgical Inc.,
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact Tove Kjær
Correspondent
Origio A/S
Knardrupvej 2
Måløv,  DK 2760
Correspondent Contact Tove Kjær
Regulation Number884.6180
Classification Product Code
MQL  
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
Predetermined Change
Control Plan Authorized		 No
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