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FDA 510(k)

TECNOL PERSONAL SHOE COVER

K-Number: K861528 · 1986-05-12

ApplicantTechnol, Inc.
Decision Date1986-05-12
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TECNOL PERSONAL SHOE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Technol, Inc.. It received FDA 510(k) clearance on 1986-05-12 under 510(k) number K861528. 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 TECNOL PERSONAL SHOE COVER?

TECNOL PERSONAL SHOE COVER is a medical device that received FDA 510(k) clearance on 1986-05-12. The listed applicant is Technol, Inc.. The 510(k) number is K861528.

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

TECNOL PERSONAL SHOE COVER received FDA 510(k) clearance on 1986-05-12, under 510(k) number K861528.

Who is the listed applicant for TECNOL PERSONAL SHOE COVER?

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

What is the FDA product code for TECNOL PERSONAL SHOE COVER?

The FDA product code for TECNOL PERSONAL SHOE COVER is FXP.

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 Technol, 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.

K884132TECNOL BUCKS TRACTION W/HEEL PROTECTOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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