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FDA 510(k)

RINSE MACHINE KR-4 KIDNEY RINSE-4

K-Number: K850799 · 1985-07-29

ApplicantMedical Technologies International, Inc.
Decision Date1985-07-29
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RINSE MACHINE KR-4 KIDNEY RINSE-4 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Technologies International, Inc.. It received FDA 510(k) clearance on 1985-07-29 under 510(k) number K850799. 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 RINSE MACHINE KR-4 KIDNEY RINSE-4?

RINSE MACHINE KR-4 KIDNEY RINSE-4 is a medical device that received FDA 510(k) clearance on 1985-07-29. The listed applicant is Medical Technologies International, Inc.. The 510(k) number is K850799.

When did RINSE MACHINE KR-4 KIDNEY RINSE-4 receive FDA 510(k) clearance?

RINSE MACHINE KR-4 KIDNEY RINSE-4 received FDA 510(k) clearance on 1985-07-29, under 510(k) number K850799.

Who is the listed applicant for RINSE MACHINE KR-4 KIDNEY RINSE-4?

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

What is the FDA product code for RINSE MACHINE KR-4 KIDNEY RINSE-4?

The FDA product code for RINSE MACHINE KR-4 KIDNEY RINSE-4 is LIF.

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Other records listing Medical Technologies 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.

K050376PROWINK935131FAMILY FIRST AID KIT

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.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated

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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