RAPIDVIT AND RAPIDWARM CLEAVE

Media, Reproductive

VITROLIFE SWEDEN AB

The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Rapidvit And Rapidwarm Cleave.

Pre-market Notification Details

Device IDK080446
510k NumberK080446
Device Name:RAPIDVIT AND RAPIDWARM CLEAVE
ClassificationMedia, Reproductive
Applicant VITROLIFE SWEDEN AB FAKTORVAGEN 13 Kungsbacka,  SE Se-434 37
ContactKjell Kjork
CorrespondentKjell Kjork
VITROLIFE SWEDEN AB FAKTORVAGEN 13 Kungsbacka,  SE Se-434 37
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-02-19
Decision Date2008-11-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07350025910536 K080446 000
07350025910529 K080446 000

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