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FDA 510(k)

FLARE DIS. NONWOVEN HEAD COVERS

K-Number: K800810 · 1980-05-20

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

Device Summary

FLARE DIS. NONWOVEN HEAD 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 K800810. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLARE DIS. NONWOVEN HEAD COVERS?

FLARE DIS. NONWOVEN HEAD 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 K800810.

When did FLARE DIS. NONWOVEN HEAD COVERS receive FDA 510(k) clearance?

FLARE DIS. NONWOVEN HEAD COVERS received FDA 510(k) clearance on 1980-05-20, under 510(k) number K800810.

Who is the listed applicant for FLARE DIS. NONWOVEN HEAD 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. NONWOVEN HEAD COVERS?

The FDA product code for FLARE DIS. NONWOVEN HEAD COVERS is FYF.

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.

K800809FLARE DIS. CONDUCTIVE&NON. SHOE COVERS

Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K954454NIOMED SURGICAL HOODAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, Inc.

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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