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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 K200680
Device Name Synvitro Hyadase
Applicant
Origio A/S, A Coopersurgical Company
Knardrupvej 2
Måløv,  DK 2760
Applicant Contact Monika Bak
Correspondent
Origio A/S, A Coopersurgical Company
Knardrupvej 2
Måløv,  DK 2760
Correspondent Contact Monika Bak
Regulation Number884.6180
Classification Product Code
MQL  
Date Received03/16/2020
Decision Date 07/17/2020
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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