MEDOJECT Fine Pen Needles

Needle, Hypodermic, Single Lumen

Chirana T. Injecta

The following data is part of a premarket notification filed by Chirana T. Injecta with the FDA for Medoject Fine Pen Needles.

Pre-market Notification Details

Device IDK220614
510k NumberK220614
Device Name:MEDOJECT Fine Pen Needles
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Chirana T. Injecta Nám. Dr. Schweitzera 194 Stará Turá,  SK 916 01
ContactZdenka Klbeckova
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-03
Decision Date2022-06-15

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