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FDA 510(k)

NIPRO NEEDLE HOLDER

K-Number: K894372 · 1989-09-28

ApplicantPharma-Plast USA, Inc.
Decision Date1989-09-28
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NIPRO NEEDLE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Pharma-Plast USA, Inc.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894372. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIPRO NEEDLE HOLDER?

NIPRO NEEDLE HOLDER is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Pharma-Plast USA, Inc.. The 510(k) number is K894372.

When did NIPRO NEEDLE HOLDER receive FDA 510(k) clearance?

NIPRO NEEDLE HOLDER received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894372.

Who is the listed applicant for NIPRO NEEDLE HOLDER?

The FDA 510(k) record lists Pharma-Plast USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIPRO NEEDLE HOLDER?

The FDA product code for NIPRO NEEDLE HOLDER is FMI.

Related Clinical Trials

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Other records listing Pharma-Plast USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K894371NIPRO SAFELET CATHK894373NIPRO DENTAL NEEDLEK894374BLOOD DRAWING NEEDLEK884978PHARMA-PLAST INSULIN INFUSION SETK871263MULTIPLE PHARMA-PLAST TRACHEAL TUBEK852443PHARMA-PLAST CLINIPAK

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Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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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