SAGE Vitrification Kit And SAGE Vitrification Warming Kit

Media, Reproductive

CooperSurgical Inc

The following data is part of a premarket notification filed by Coopersurgical Inc with the FDA for Sage Vitrification Kit And Sage Vitrification Warming Kit.

Pre-market Notification Details

Device IDK170560
510k NumberK170560
Device Name:SAGE Vitrification Kit And SAGE Vitrification Warming Kit
ClassificationMedia, Reproductive
Applicant CooperSurgical Inc 95 Corporate Drive Trumbull,  CT  06611
ContactTove Kjær
CorrespondentTove Kjær
Origio A/S Knardrupvej 2 Malov,  DK 2760
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-27
Decision Date2017-04-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60888937830486 K170560 000
60888937830448 K170560 000
60888937027138 K170560 000

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