PLPT LDV (Low Dead Volume) Sterile Syringe— 510(k) K210443
Substantially EquivalentPoonglim Pharmatech, Inc.
FDA 510(k) clearance K210443 for PLPT LDV (Low Dead Volume) Sterile Syringe, Substantially Equivalent on 2021-02-16. Applicant: Poonglim Pharmatech, Inc.. Device class: 2.
Clearance details
- Applicant
- Poonglim Pharmatech, Inc.
- Product code
- Code QNQ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gunsan, KR
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More clearances from Poonglim Pharmatech, Inc.
view all- K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
- K221860 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
- K210444 — EZ-Injec LDV Sterile Safety Needle
- K192222 — EZ-Inject Single use Needle
- K172483 — Kopac Sterile Needle
Data sourced from openFDA. This site is unofficial and independent of the FDA.