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FDA 510(k)

RENACLEAN SH DIALYZER CLEANING SYSTEM

K-Number: K033505 · 2004-04-27

ApplicantMinntech Corp.
Decision Date2004-04-27
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENACLEAN SH DIALYZER CLEANING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 2004-04-27 under 510(k) number K033505. 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 RENACLEAN SH DIALYZER CLEANING SYSTEM?

RENACLEAN SH DIALYZER CLEANING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-27. The listed applicant is Minntech Corp.. The 510(k) number is K033505.

When did RENACLEAN SH DIALYZER CLEANING SYSTEM receive FDA 510(k) clearance?

RENACLEAN SH DIALYZER CLEANING SYSTEM received FDA 510(k) clearance on 2004-04-27, under 510(k) number K033505.

Who is the listed applicant for RENACLEAN SH DIALYZER CLEANING SYSTEM?

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

What is the FDA product code for RENACLEAN SH DIALYZER CLEANING SYSTEM?

The FDA product code for RENACLEAN SH DIALYZER CLEANING SYSTEM is LIF.

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Other records listing Minntech Corp. 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.

K120306RAPICIDE OPA-28K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMK071298HF JUNIOR HEMOFILTERK050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORK014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLERK991137ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER

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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 CompanyK024076MAKY 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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