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FDA 510(k)

CARETEX SHOE COVERS

K-Number: K864550 · 1986-12-24

ApplicantJames River Corp.
Decision Date1986-12-24
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARETEX SHOE COVERS is the device name listed in this FDA 510(k) record. The listed applicant is James River Corp.. It received FDA 510(k) clearance on 1986-12-24 under 510(k) number K864550. 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 CARETEX SHOE COVERS?

CARETEX SHOE COVERS is a medical device that received FDA 510(k) clearance on 1986-12-24. The listed applicant is James River Corp.. The 510(k) number is K864550.

When did CARETEX SHOE COVERS receive FDA 510(k) clearance?

CARETEX SHOE COVERS received FDA 510(k) clearance on 1986-12-24, under 510(k) number K864550.

Who is the listed applicant for CARETEX SHOE COVERS?

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

What is the FDA product code for CARETEX SHOE COVERS?

The FDA product code for CARETEX SHOE COVERS is FXP.

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Other records listing James River 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.

K894505COTOLIN DRAIN SPONGE AND DRESSING SPONGEK894147VISULIN TRANSPARENT ADHESIVE DRESSINGK894034MODIFIED LABELING OF SURGICAL GLOVESK892580CARETOUCH EXAMINATION GLOVESK893939ISOLATION MASKSK890459JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES

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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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