MEDICULT IVM SYSTEM

Media, Reproductive

MEDICULT A/S

The following data is part of a premarket notification filed by Medicult A/s with the FDA for Medicult Ivm System.

Pre-market Notification Details

Device IDK041284
510k NumberK041284
Device Name:MEDICULT IVM SYSTEM
ClassificationMedia, Reproductive
Applicant MEDICULT A/S 9915 CAM. CHIRIMOLLA San Diego,  CA  92131
ContactRonald G Leonardi
CorrespondentRonald G Leonardi
MEDICULT A/S 9915 CAM. CHIRIMOLLA San Diego,  CA  92131
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2004-05-13
Decision Date2004-11-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60888937804128 K041284 000

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