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FDA 510(k)

DISPOSABLE SHOE COVER

K-Number: K894383 · 1989-09-12

ApplicantAmerican Threshold Industries, Inc.
Decision Date1989-09-12
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SHOE COVER is the device name listed in this FDA 510(k) record. The listed applicant is American Threshold Industries, Inc.. It received FDA 510(k) clearance on 1989-09-12 under 510(k) number K894383. 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 DISPOSABLE SHOE COVER?

DISPOSABLE SHOE COVER is a medical device that received FDA 510(k) clearance on 1989-09-12. The listed applicant is American Threshold Industries, Inc.. The 510(k) number is K894383.

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

DISPOSABLE SHOE COVER received FDA 510(k) clearance on 1989-09-12, under 510(k) number K894383.

Who is the listed applicant for DISPOSABLE SHOE COVER?

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

What is the FDA product code for DISPOSABLE SHOE COVER?

The FDA product code for DISPOSABLE SHOE COVER is FXP.

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Other records listing American Threshold Industries, 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.

K971483SECURE-WRAP (TM) STERILIZATION WRAPK953879SURGEON'S CAPK953878BOUFFANT CAPK952115BARRIER GOWN, KOOL-GARD BACKLESS GOWNK952114KOOL GARD SINGLES GOWNK952116COVER GOWN

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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.

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