OVOIL-150, MODEL 5002

Media, Reproductive

VITROLIFE SWEDEN AB

The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Ovoil-150, Model 5002.

Pre-market Notification Details

Device IDK991351
510k NumberK991351
Device Name:OVOIL-150, MODEL 5002
ClassificationMedia, Reproductive
Applicant VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg,  SE Se-412 63
ContactEiler Anderson
CorrespondentEiler Anderson
VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg,  SE Se-412 63
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-19
Decision Date2000-02-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07350025910307 K991351 000

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