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FDA 510(k)

ASSIST HEADER CLEANER

K-Number: K043126 · 2005-02-03

ApplicantAlcavis International, Inc.
Decision Date2005-02-03
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASSIST HEADER CLEANER is the device name listed in this FDA 510(k) record. The listed applicant is Alcavis International, Inc.. It received FDA 510(k) clearance on 2005-02-03 under 510(k) number K043126. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSIST HEADER CLEANER?

ASSIST HEADER CLEANER is a medical device that received FDA 510(k) clearance on 2005-02-03. The listed applicant is Alcavis International, Inc.. The 510(k) number is K043126.

When did ASSIST HEADER CLEANER receive FDA 510(k) clearance?

ASSIST HEADER CLEANER received FDA 510(k) clearance on 2005-02-03, under 510(k) number K043126.

Who is the listed applicant for ASSIST HEADER CLEANER?

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

What is the FDA product code for ASSIST HEADER CLEANER?

The FDA product code for ASSIST HEADER CLEANER is LIF.

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Other records listing Alcavis International, 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.

K082858EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSERK061467EXSEPT WC WOUND CLEANSER

Related Devices (Code: LIF)

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.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International IncorporatedK992016AMUKIN DAmuchina Intl., 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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