EZ-Inject Single Use Needle

Needle, Hypodermic, Single Lumen

POONGLIM Pharmatech Inc.

The following data is part of a premarket notification filed by Poonglim Pharmatech Inc. with the FDA for Ez-inject Single Use Needle.

Pre-market Notification Details

Device IDK192222
510k NumberK192222
Device Name:EZ-Inject Single Use Needle
ClassificationNeedle, Hypodermic, Single Lumen
Applicant POONGLIM Pharmatech Inc. 21, Jayumuyeok 1-gil Gunsan-si,  KR 54001
ContactCho Hee Min
CorrespondentPeter Chung
Plus Global 300 Atwood Pittsburgh,  PA  15213
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-16
Decision Date2020-05-12

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