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FDA 510(k)

DISPOSABLE SHOE COVERS AND NURSES CAPS

K-Number: K862726 · 1986-08-01

ApplicantAbco Dealers, Inc.
Decision Date1986-08-01
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SHOE COVERS AND NURSES CAPS is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K862726. 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 COVERS AND NURSES CAPS?

DISPOSABLE SHOE COVERS AND NURSES CAPS is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K862726.

When did DISPOSABLE SHOE COVERS AND NURSES CAPS receive FDA 510(k) clearance?

DISPOSABLE SHOE COVERS AND NURSES CAPS received FDA 510(k) clearance on 1986-08-01, under 510(k) number K862726.

Who is the listed applicant for DISPOSABLE SHOE COVERS AND NURSES CAPS?

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

What is the FDA product code for DISPOSABLE SHOE COVERS AND NURSES CAPS?

The FDA product code for DISPOSABLE SHOE COVERS AND NURSES CAPS is FXP.

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Other records listing Abco Dealers, 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.

K905025DIGITAL THERMOMETER KITSK882304DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)K880892BLOOD COLLECTING NEEDLE AND HOLDERSK880894ALLERGIST SYRINGESK872875STRETCH GAUZE BANDAGESK872874MICROSCOPE COVER GLASSES

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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.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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