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FDA 510(k)

MAKY 21.1 DIALYZER REPROCESSING SYSTEM

K-Number: K024076 · 2003-09-26

ApplicantHdc Maquinolas, LLC
Decision Date2003-09-26
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAKY 21.1 DIALYZER REPROCESSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hdc Maquinolas, LLC. It received FDA 510(k) clearance on 2003-09-26 under 510(k) number K024076. 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 MAKY 21.1 DIALYZER REPROCESSING SYSTEM?

MAKY 21.1 DIALYZER REPROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-26. The listed applicant is Hdc Maquinolas, LLC. The 510(k) number is K024076.

When did MAKY 21.1 DIALYZER REPROCESSING SYSTEM receive FDA 510(k) clearance?

MAKY 21.1 DIALYZER REPROCESSING SYSTEM received FDA 510(k) clearance on 2003-09-26, under 510(k) number K024076.

Who is the listed applicant for MAKY 21.1 DIALYZER REPROCESSING SYSTEM?

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

What is the FDA product code for MAKY 21.1 DIALYZER REPROCESSING SYSTEM?

The FDA product code for MAKY 21.1 DIALYZER REPROCESSING SYSTEM is LIF.

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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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 TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International IncorporatedK992016AMUKIN DAmuchina Intl., Inc.

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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