G-MM, MODEL 10038

Media, Reproductive

VITROLIFE SWEDEN AB

The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for G-mm, Model 10038.

Pre-market Notification Details

Device IDK021894
510k NumberK021894
Device Name:G-MM, MODEL 10038
ClassificationMedia, Reproductive
Applicant VITROLIFE SWEDEN AB 1800 MASSACHUSETTS AVENUE NW Washington,  DC  20036 -1800
ContactGary L Yingling
CorrespondentGary L Yingling
VITROLIFE SWEDEN AB 1800 MASSACHUSETTS AVENUE NW Washington,  DC  20036 -1800
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-10
Decision Date2002-09-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07350025910130 K021894 000

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