EZ-Injec LDV Sterile Safety Needle— 510(k) K210444

Name: FDA 510(k) clearance K210444
Creator: U.S. Food and Drug Administration
Published: 2021-02-16

Substantially Equivalent

Poonglim Pharmatech, Inc.

FDA 510(k) clearance K210444 for EZ-Injec LDV Sterile Safety Needle, Substantially Equivalent on 2021-02-16. Applicant: Poonglim Pharmatech, Inc.. Device class: 2.

Clearance details

Applicant: Poonglim Pharmatech, Inc.
Product code: Code QNS
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2021-02-16
Decision date: 2021-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunsan, KR

Download summary PDF View on FDA.gov ↗

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K210443 — PLPT LDV (Low Dead Volume) Sterile Syringe2021-02-16
K192222 — EZ-Inject Single use Needle2020-05-12
K172483 — Kopac Sterile Needle2018-06-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.