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FDA 510(k)

FLARE DIS. CONDUCTIVE&NON. SHOE COVERS

K-Number: K800809 · 1980-05-20

ApplicantFlare Products, Inc.
Decision Date1980-05-20
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLARE DIS. CONDUCTIVE&NON. SHOE COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Flare Products, Inc.. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K800809. 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 FLARE DIS. CONDUCTIVE&NON. SHOE COVERS?

FLARE DIS. CONDUCTIVE&NON. SHOE COVERS is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is Flare Products, Inc.. The 510(k) number is K800809.

When did FLARE DIS. CONDUCTIVE&NON. SHOE COVERS receive FDA 510(k) clearance?

FLARE DIS. CONDUCTIVE&NON. SHOE COVERS received FDA 510(k) clearance on 1980-05-20, under 510(k) number K800809.

Who is the listed applicant for FLARE DIS. CONDUCTIVE&NON. SHOE COVERS?

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

What is the FDA product code for FLARE DIS. CONDUCTIVE&NON. SHOE COVERS?

The FDA product code for FLARE DIS. CONDUCTIVE&NON. 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 Flare Products, 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.

K800810FLARE DIS. NONWOVEN HEAD COVERS

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

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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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