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FDA 510(k)

NON-CONDUCTIVE SHOE COVERS

K-Number: K801616 · 1980-08-04

ApplicantProcter & Gamble Mfg. Co.
Decision Date1980-08-04
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NON-CONDUCTIVE SHOE COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Procter & Gamble Mfg. Co.. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K801616. 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 NON-CONDUCTIVE SHOE COVERS?

NON-CONDUCTIVE SHOE COVERS is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Procter & Gamble Mfg. Co.. The 510(k) number is K801616.

When did NON-CONDUCTIVE SHOE COVERS receive FDA 510(k) clearance?

NON-CONDUCTIVE SHOE COVERS received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801616.

Who is the listed applicant for NON-CONDUCTIVE SHOE COVERS?

The FDA 510(k) record lists Procter & Gamble Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-CONDUCTIVE SHOE COVERS?

The FDA product code for NON-CONDUCTIVE SHOE COVERS is FXP.

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Other records listing Procter & Gamble Mfg. Co. 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.

K873457SCENTED OR SCENTED DEODORIZED MENSTRUAL PADSK873036ATTENDS INCONTINENT BRIEFK864673UNSCENTED MENSTRUAL PADK861863MODIFIED PROTECTIVE GARMENTK862348SINGLE-USE PATIENT UNDERPADK860598MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS

View all 72 devices →

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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