ICSI-100

Media, Reproductive

VITROLIFE SWEDEN AB

The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Icsi-100.

Pre-market Notification Details

Device IDK043116
510k NumberK043116
Device Name:ICSI-100
ClassificationMedia, Reproductive
Applicant VITROLIFE SWEDEN AB FAKTORVAGEN 13 Kungsbacka,  SE Se-434 37
ContactMorgan Hugosson
CorrespondentMorgan Hugosson
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 Received2004-11-10
Decision Date2005-01-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17350025910274 K043116 000

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