MiniLoad Syringe

Syringe, Piston

OcuJect, LLC

The following data is part of a premarket notification filed by Ocuject, Llc with the FDA for Miniload Syringe.

Pre-market Notification Details

Device IDK202432
510k NumberK202432
Device Name:MiniLoad Syringe
ClassificationSyringe, Piston
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 CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-25
Decision Date2021-02-19

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