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FDA 510(k)

ANOGO DISPOSABLE SHOE COVER

K-Number: K812105 · 1981-09-11

ApplicantAnago, Inc.
Decision Date1981-09-11
Product CodeBWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANOGO DISPOSABLE SHOE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Anago, Inc.. It received FDA 510(k) clearance on 1981-09-11 under 510(k) number K812105. The device is classified under product code BWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANOGO DISPOSABLE SHOE COVER?

ANOGO DISPOSABLE SHOE COVER is a medical device that received FDA 510(k) clearance on 1981-09-11. The listed applicant is Anago, Inc.. The 510(k) number is K812105.

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

ANOGO DISPOSABLE SHOE COVER received FDA 510(k) clearance on 1981-09-11, under 510(k) number K812105.

Who is the listed applicant for ANOGO DISPOSABLE SHOE COVER?

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

What is the FDA product code for ANOGO DISPOSABLE SHOE COVER?

The FDA product code for ANOGO DISPOSABLE SHOE COVER is BWP.

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Other records listing Anago, 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.

K925659U.C.E.Z. LENS CLEANER KITK930161ANAGO SPINAL ANESTHESIA TRAYK926590ANAGO DISPOSABLE INSTANT COLD PACKK926137ANAGO FEM-COOL/FEM-COOL PETITEK926589ANAGO WARM PACKK920615ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT

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Related Devices (Code: BWP)

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.

K880384KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOTKimberly-Clark Corp.K831952SURGICAL APPAREL SHOE COVERSSudreca Surgical Dressings, Inc.

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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