FDA 510(k)

PLPT LDV (Low Dead Volume) Sterile Syringe

K-번호: K210443 · 2021-02-16

결정일2021-02-16

제품 코드QNQ

자문 위원회HO

결정Substantially Equivalent

기기 요약

PLPT LDV (Low Dead Volume) Sterile Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Poonglim Pharmatech, Inc.. It received FDA 510(k) clearance on 2021-02-16 under 510(k) number K210443. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PLPT LDV (Low Dead Volume) Sterile Syringe?

PLPT LDV (Low Dead Volume) Sterile Syringe is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Poonglim Pharmatech, Inc.. The 510(k) number is K210443.

When did PLPT LDV (Low Dead Volume) Sterile Syringe receive FDA 510(k) clearance?

PLPT LDV (Low Dead Volume) Sterile Syringe received FDA 510(k) clearance on 2021-02-16, under 510(k) number K210443.

Who is the listed applicant for PLPT LDV (Low Dead Volume) Sterile Syringe?

The FDA 510(k) record lists Poonglim Pharmatech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLPT LDV (Low Dead Volume) Sterile Syringe?

The FDA product code for PLPT LDV (Low Dead Volume) Sterile Syringe is QNQ.

Poonglim Pharmatech, Inc.를 신청인으로 등재한 기타 기록

K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe K221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe K210444EZ-Injec LDV Sterile Safety Needle K192222EZ-Inject Single use Needle K172483Kopac Sterile Needle

관련 기기 (코드: QNQ)

K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety SyringeCMT Health PTE., Ltd.K250127TSK SyringeTsk Laboratory, Japan K250138Small Volume 0.2mL SyringeProsum Medical Limited 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.K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc.

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