Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OREX SHOE COVERS

K-Number: K943034 · 1995-01-02

ApplicantThantex Specialties, Inc.
Decision Date1995-01-02
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OREX SHOE COVERS 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 1995-01-02 under 510(k) number K943034. The device is classified under product code FXP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OREX SHOE COVERS?

OREX SHOE COVERS is a medical device that received FDA 510(k) clearance on 1995-01-02. The listed applicant is Thantex Specialties, Inc.. The 510(k) number is K943034.

When did OREX SHOE COVERS receive FDA 510(k) clearance?

OREX SHOE COVERS received FDA 510(k) clearance on 1995-01-02, under 510(k) number K943034.

Who is the listed applicant for OREX SHOE COVERS?

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 SHOE COVERS?

The FDA product code for OREX SHOE COVERS is FXP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 21 devices →

Related Devices (Code: FXP)

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.

K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.K971191FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.K970815CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.K961342SHOE COVER, NON-STERILECopioumed Intl., Inc.K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.K952937NIOMED NON-SKID SHOE COVERSAmerasia Corp.

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.

↑