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FDA 510(k)

ONGARD 2 GALLON CHEMO SHARPS CONTAINER

K-Number: K933674 · 1994-05-16

ApplicantOngard Systems, Inc.
Decision Date1994-05-16
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ONGARD 2 GALLON CHEMO SHARPS CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Ongard Systems, Inc.. It received FDA 510(k) clearance on 1994-05-16 under 510(k) number K933674. 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 ONGARD 2 GALLON CHEMO SHARPS CONTAINER?

ONGARD 2 GALLON CHEMO SHARPS CONTAINER is a medical device that received FDA 510(k) clearance on 1994-05-16. The listed applicant is Ongard Systems, Inc.. The 510(k) number is K933674.

When did ONGARD 2 GALLON CHEMO SHARPS CONTAINER receive FDA 510(k) clearance?

ONGARD 2 GALLON CHEMO SHARPS CONTAINER received FDA 510(k) clearance on 1994-05-16, under 510(k) number K933674.

Who is the listed applicant for ONGARD 2 GALLON CHEMO SHARPS CONTAINER?

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

What is the FDA product code for ONGARD 2 GALLON CHEMO SHARPS CONTAINER?

The FDA product code for ONGARD 2 GALLON CHEMO SHARPS CONTAINER 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 Ongard Systems, 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.

K942323ONGARD 2 GALLON SHARPS CONTAINERK933274ONGARD 3 QUART SHARPS CONTAINER

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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