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FDA 510(k)

OREX MEDICAL BEDDING

K-Number: K944953 · 1994-12-02

ApplicantThantex Specialties, Inc.
Decision Date1994-12-02
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OREX MEDICAL BEDDING 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 1994-12-02 under 510(k) number K944953. The device is classified under product code KME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OREX MEDICAL BEDDING?

OREX MEDICAL BEDDING is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is Thantex Specialties, Inc.. The 510(k) number is K944953.

When did OREX MEDICAL BEDDING receive FDA 510(k) clearance?

OREX MEDICAL BEDDING received FDA 510(k) clearance on 1994-12-02, under 510(k) number K944953.

Who is the listed applicant for OREX MEDICAL BEDDING?

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 OREX MEDICAL BEDDING?

The FDA product code for OREX MEDICAL BEDDING is KME.

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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.

K970547ISOLYSER SDS SHARPS CONTAINERK961083OREX SURGEON'S VESTK942200ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPSK943626ISOLYSER SHARPS MANAGEMENT SYSTEM SMSK945755OREX(R) O.R EQUIPMENT DRAPESK945223OREX ISOLATION GOWN

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Related Devices (Code: KME)

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.

K042145READY-HEAT BLANKETTechtrade, LLCK933636DISPOSE-A-SHEETBelmac Healthcare Corp.K932539DOCTOR DOWN --RESCUE WRAPThree Dog DownK922143AMERICAN BURN SHEETAmerican Silk Sutures, Inc.K915303FOIL BABY BUNTINGGam Industries, Inc.K912257CHEM-SLEEVE BHaz-Med, Inc.

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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