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FDA 510(k)

PHARMA-PLAST NEEDLE

K-Number: K852442 · 1985-09-20

ApplicantPharma-Plast USA, Inc.
Decision Date1985-09-20
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHARMA-PLAST NEEDLE 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 1985-09-20 under 510(k) number K852442. 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 PHARMA-PLAST NEEDLE?

PHARMA-PLAST NEEDLE is a medical device that received FDA 510(k) clearance on 1985-09-20. The listed applicant is Pharma-Plast USA, Inc.. The 510(k) number is K852442.

When did PHARMA-PLAST NEEDLE receive FDA 510(k) clearance?

PHARMA-PLAST NEEDLE received FDA 510(k) clearance on 1985-09-20, under 510(k) number K852442.

Who is the listed applicant for PHARMA-PLAST NEEDLE?

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 PHARMA-PLAST NEEDLE?

The FDA product code for PHARMA-PLAST NEEDLE is FMI.

Related Clinical Trials

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.

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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 NEEDLEK894372NIPRO NEEDLE HOLDERK884978PHARMA-PLAST INSULIN INFUSION SETK871263MULTIPLE PHARMA-PLAST TRACHEAL TUBE

View all 9 devices →

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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