Go Dose System

Calculator, Drug Dose

ELI LILLY AND COMPANY

The following data is part of a premarket notification filed by Eli Lilly And Company with the FDA for Go Dose System.

Pre-market Notification Details

Device IDK160949
510k NumberK160949
Device Name:Go Dose System
ClassificationCalculator, Drug Dose
Applicant ELI LILLY AND COMPANY LILLY CORPORATE CENTER Indianapolis,  IN  46285
ContactSumitra M Ghate
CorrespondentSumitra M Ghate
ELI LILLY AND COMPANY LILLY CORPORATE CENTER Indianapolis,  IN  46285
Product CodeNDC  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-05
Decision Date2016-12-22
Summary:summary

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