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FDA 510(k)

R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE

K-Number: K852615 · 1986-03-21

ApplicantMedical Hospital Equipment
Decision Date1986-03-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Hospital Equipment. It received FDA 510(k) clearance on 1986-03-21 under 510(k) number K852615. 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 R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE?

R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE is a medical device that received FDA 510(k) clearance on 1986-03-21. The listed applicant is Medical Hospital Equipment. The 510(k) number is K852615.

When did R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE receive FDA 510(k) clearance?

R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE received FDA 510(k) clearance on 1986-03-21, under 510(k) number K852615.

Who is the listed applicant for R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE?

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

What is the FDA product code for R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE?

The FDA product code for R.R. AGHI HYPODERMIC SINGLE LUMEN 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 Medical Hospital Equipment 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.

K852616MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILEK852503R.R. PRONTO SIRINGA

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

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

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