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FDA 510(k)

FAR-EAST SHOE COVERS

K-Number: K971191 · 1997-07-10

ApplicantFar East Science & Technology Development Co., Ltd.
Decision Date1997-07-10
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FAR-EAST SHOE COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Far East Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 1997-07-10 under 510(k) number K971191. 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 FAR-EAST SHOE COVERS?

FAR-EAST SHOE COVERS is a medical device that received FDA 510(k) clearance on 1997-07-10. The listed applicant is Far East Science & Technology Development Co., Ltd.. The 510(k) number is K971191.

When did FAR-EAST SHOE COVERS receive FDA 510(k) clearance?

FAR-EAST SHOE COVERS received FDA 510(k) clearance on 1997-07-10, under 510(k) number K971191.

Who is the listed applicant for FAR-EAST SHOE COVERS?

The FDA 510(k) record lists Far East Science & Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAR-EAST SHOE COVERS?

The FDA product code for FAR-EAST SHOE COVERS is FXP.

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Other records listing Far East Science & Technology Development Co., Ltd. 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.

K970988FAR-EAST BOUFFANT CAPSK971702FAR-EAST BARRIER GOWNS

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.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.K952897NIOMED 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.

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