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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 K180740
Device Name VitriGuard
Applicant
Origio A/S
Knardrupvej 2
Måløv,  DK 2760
Applicant Contact Roaida Johnson
Correspondent
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Correspondent Contact Roaida Johnson
Regulation Number884.6160
Classification Product Code
MQK  
Date Received03/22/2018
Decision Date 05/04/2018
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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