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FDA 510(k)

FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS

K-Number: K954349 · 1995-12-15

ApplicantMinntech Corp.
Decision Date1995-12-15
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 1995-12-15 under 510(k) number K954349. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS?

FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS is a medical device that received FDA 510(k) clearance on 1995-12-15. The listed applicant is Minntech Corp.. The 510(k) number is K954349.

When did FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS receive FDA 510(k) clearance?

FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS received FDA 510(k) clearance on 1995-12-15, under 510(k) number K954349.

Who is the listed applicant for FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS?

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 FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS?

The FDA product code for FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS is FIP.

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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 HEMOCONCENTRATORK033505RENACLEAN SH DIALYZER CLEANING SYSTEMK014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

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Related Devices (Code: FIP)

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.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, 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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