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FDA 510(k)

HOLLOW FIBER DIALIZER MODEL TRIEX-3

K-Number: K791857 · 1979-11-05

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1979-11-05
Product Code
DecisionSubstantially Equivalent

Device Summary

HOLLOW FIBER DIALIZER MODEL TRIEX-3 is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K791857. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLLOW FIBER DIALIZER MODEL TRIEX-3?

HOLLOW FIBER DIALIZER MODEL TRIEX-3 is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K791857.

When did HOLLOW FIBER DIALIZER MODEL TRIEX-3 receive FDA 510(k) clearance?

HOLLOW FIBER DIALIZER MODEL TRIEX-3 received FDA 510(k) clearance on 1979-11-05, under 510(k) number K791857.

Who is the listed applicant for HOLLOW FIBER DIALIZER MODEL TRIEX-3?

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

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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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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