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FDA 510(k)

REUSABLE LIQUIDPROOF BOOTIE

K-Number: K925815 · 1993-07-09

ApplicantAmsco Sterile Recoveries, Inc.
Decision Date1993-07-09
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REUSABLE LIQUIDPROOF BOOTIE is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Sterile Recoveries, Inc.. It received FDA 510(k) clearance on 1993-07-09 under 510(k) number K925815. 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 REUSABLE LIQUIDPROOF BOOTIE?

REUSABLE LIQUIDPROOF BOOTIE is a medical device that received FDA 510(k) clearance on 1993-07-09. The listed applicant is Amsco Sterile Recoveries, Inc.. The 510(k) number is K925815.

When did REUSABLE LIQUIDPROOF BOOTIE receive FDA 510(k) clearance?

REUSABLE LIQUIDPROOF BOOTIE received FDA 510(k) clearance on 1993-07-09, under 510(k) number K925815.

Who is the listed applicant for REUSABLE LIQUIDPROOF BOOTIE?

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

What is the FDA product code for REUSABLE LIQUIDPROOF BOOTIE?

The FDA product code for REUSABLE LIQUIDPROOF BOOTIE is FXP.

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Other records listing Amsco Sterile Recoveries, 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.

K932522AMSCO STERILE RECOVERIES SURGICAL PACKSK931143AMSCO STERILE RECOVERIES ABSORBENT TOWELSK931146SURGICAL DRAPES, MODIFICATIONK931145NON-STERILE ISOLATION GOWNK931144STERILE SURGEON'S GOWN, MODIFICATIONK931875AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE

View all 12 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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