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FDA 510(k)

CHURCHILL HABER POINT NEEDLE ADMIN. SET

K-Number: K850420 · 1985-04-24

ApplicantChurchill Corp.
Decision Date1985-04-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHURCHILL HABER POINT NEEDLE ADMIN. SET is the device name listed in this FDA 510(k) record. The listed applicant is Churchill Corp.. It received FDA 510(k) clearance on 1985-04-24 under 510(k) number K850420. 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 CHURCHILL HABER POINT NEEDLE ADMIN. SET?

CHURCHILL HABER POINT NEEDLE ADMIN. SET is a medical device that received FDA 510(k) clearance on 1985-04-24. The listed applicant is Churchill Corp.. The 510(k) number is K850420.

When did CHURCHILL HABER POINT NEEDLE ADMIN. SET receive FDA 510(k) clearance?

CHURCHILL HABER POINT NEEDLE ADMIN. SET received FDA 510(k) clearance on 1985-04-24, under 510(k) number K850420.

Who is the listed applicant for CHURCHILL HABER POINT NEEDLE ADMIN. SET?

The FDA 510(k) record lists Churchill Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHURCHILL HABER POINT NEEDLE ADMIN. SET?

The FDA product code for CHURCHILL HABER POINT NEEDLE ADMIN. SET is FMI.

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Other records listing Churchill Corp. 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.

K880026CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETSK880051ENTERAL BAG/SETK880025CHURCHILL 0.22 MICRON LIQUID FILTER SETSK880027CHURCHILL 1.2 MICRON LIQUID FILTER SETK870395CHURCHILL PARENTERAL NUTRITION BAG - EVAK872585CHURCHILL-CATH

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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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