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FDA 510(k)

TORAY FILTRYZER DIALYZERS

K-Number: K884339 · 1989-03-17

ApplicantToray Industries (America), Inc.
Decision Date1989-03-17
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TORAY FILTRYZER DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Toray Industries (America), Inc.. It received FDA 510(k) clearance on 1989-03-17 under 510(k) number K884339. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORAY FILTRYZER DIALYZERS?

TORAY FILTRYZER DIALYZERS is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is Toray Industries (America), Inc.. The 510(k) number is K884339.

When did TORAY FILTRYZER DIALYZERS receive FDA 510(k) clearance?

TORAY FILTRYZER DIALYZERS received FDA 510(k) clearance on 1989-03-17, under 510(k) number K884339.

Who is the listed applicant for TORAY FILTRYZER DIALYZERS?

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

What is the FDA product code for TORAY FILTRYZER DIALYZERS?

The FDA product code for TORAY FILTRYZER DIALYZERS is FJI.

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Other records listing Toray Industries (America), 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.

K042370TORAYGUIDE GUIDEWIREK030050TORAYSULFONE DIALYZER, BS-L SERIESK002512TORAYSULFONE DIALYZERK994198HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0LK942681FILTRYZERK935471FILTRYZER(TM)

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Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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