LIFE4C

Media, Corneal Storage

NUMEDIS, INC.

The following data is part of a premarket notification filed by Numedis, Inc. with the FDA for Life4c.

Pre-market Notification Details

Device IDK063304
510k NumberK063304
Device Name:LIFE4C
ClassificationMedia, Corneal Storage
Applicant NUMEDIS, INC. 188 BUMSTEAD RD. Monson,  MA  01057
ContactMary E Freddo
CorrespondentMary E Freddo
NUMEDIS, INC. 188 BUMSTEAD RD. Monson,  MA  01057
Product CodeLYX  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-01
Decision Date2007-12-21
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.