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FDA 510(k)

SHOE COVER

K-Number: K940226 · 1994-09-26

ApplicantDerekduck Industries Corp.
Decision Date1994-09-26
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHOE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Derekduck Industries Corp.. It received FDA 510(k) clearance on 1994-09-26 under 510(k) number K940226. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHOE COVER?

SHOE COVER is a medical device that received FDA 510(k) clearance on 1994-09-26. The listed applicant is Derekduck Industries Corp.. The 510(k) number is K940226.

When did SHOE COVER receive FDA 510(k) clearance?

SHOE COVER received FDA 510(k) clearance on 1994-09-26, under 510(k) number K940226.

Who is the listed applicant for SHOE COVER?

The FDA 510(k) record lists Derekduck Industries Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHOE COVER?

The FDA product code for SHOE COVER is LYU.

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.

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Other records listing Derekduck Industries Corp. 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.

K942351DI ISOLATION GOWNK940228BOUFFANT CAP

Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., 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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