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FDA 510(k)

ISOLYSER SDS SHARPS CONTAINER

K-Number: K970547 · 1997-07-18

ApplicantThantex Specialties, Inc.
Decision Date1997-07-18
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISOLYSER SDS SHARPS CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Thantex Specialties, Inc.. It received FDA 510(k) clearance on 1997-07-18 under 510(k) number K970547. 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 ISOLYSER SDS SHARPS CONTAINER?

ISOLYSER SDS SHARPS CONTAINER is a medical device that received FDA 510(k) clearance on 1997-07-18. The listed applicant is Thantex Specialties, Inc.. The 510(k) number is K970547.

When did ISOLYSER SDS SHARPS CONTAINER receive FDA 510(k) clearance?

ISOLYSER SDS SHARPS CONTAINER received FDA 510(k) clearance on 1997-07-18, under 510(k) number K970547.

Who is the listed applicant for ISOLYSER SDS SHARPS CONTAINER?

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

What is the FDA product code for ISOLYSER SDS SHARPS CONTAINER?

The FDA product code for ISOLYSER SDS SHARPS CONTAINER is FMI.

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Other records listing Thantex Specialties, 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.

K961083OREX SURGEON'S VESTK942200ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPSK943626ISOLYSER SHARPS MANAGEMENT SYSTEM SMSK945755OREX(R) O.R EQUIPMENT DRAPESK945223OREX ISOLATION GOWNK944859OREX SURGICAL DRAPES

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Related Devices (Code: FMI)

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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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