SteriCap Mini Needle And Standard Needles

Needle, Hypodermic, Single Lumen

OcuJect, LLC

The following data is part of a premarket notification filed by Ocuject, Llc with the FDA for Stericap Mini Needle And Standard Needles.

Pre-market Notification Details

Device IDK212805
510k NumberK212805
Device Name:SteriCap Mini Needle And Standard Needles
ClassificationNeedle, Hypodermic, Single Lumen
Applicant OcuJect, LLC 1441 Avocado Ave, Suite 204 Newport Beach,  CA  92660
ContactRebecca K. Pine
CorrespondentRebecca K. Pine
OcuJect, LLC 1441 Avocado Ave, Suite 204 Newport Beach,  CA  92660
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-02
Decision Date2021-09-30

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