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FDA 510(k)

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

K-Number: K221860 · 2023-09-15

ApplicantPoonglim Pharmatech, Inc.
Decision Date2023-09-15
Product CodeQNQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe is a medical device manufactured by Poonglim Pharmatech, Inc.. It received FDA 510(k) clearance on 2023-09-15 under approval number K221860. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe?

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by Poonglim Pharmatech, Inc.. The 510(k) number is K221860.

When was PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe approved by the FDA?

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe received FDA 510(k) clearance on 2023-09-15, under approval number K221860.

What company makes PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe?

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe is manufactured by Poonglim Pharmatech, Inc..

What is the FDA product code for PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe?

The FDA product code for PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe is QNQ.

Other Devices by Poonglim Pharmatech, Inc.

K172483Kopac Sterile Needle K192222EZ-Inject Single use Needle K210443PLPT LDV (Low Dead Volume) Sterile Syringe K210444EZ-Injec LDV Sterile Safety Needle K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

Related Devices (Code: QNQ)

K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. K213013Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV SyringeJeil Tech Co., Ltd. K220083LDV((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc. K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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