NIO-I

Needle, Hypodermic, Single Lumen

Einstein Works LLC

The following data is part of a premarket notification filed by Einstein Works Llc with the FDA for Nio-i.

Pre-market Notification Details

Device IDK211395
510k NumberK211395
Device Name:NIO-I
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Einstein Works LLC 5312 Elm St Houston,  TX  77081
ContactRoy Bachrach
CorrespondentRoy Bachrach
Einstein Works LLC 5312 Elm St Houston,  TX  77081
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-05
Decision Date2021-07-28

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