ICSI CUMULASE

Media, Reproductive

MEDICULT A/S

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

Pre-market Notification Details

Device IDK081639
510k NumberK081639
Device Name:ICSI CUMULASE
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 Received2008-06-11
Decision Date2008-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20888937817984 K081639 000

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