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FDA 510(k)

CLIRANS TE08 HOLLOW FIBER DIALYZER

K-Number: K823768 · 1983-01-08

ApplicantTerumo Medical Corp.
Decision Date1983-01-08
Product CodeHRN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CLIRANS TE08 HOLLOW FIBER DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1983-01-08 under 510(k) number K823768. The device is classified under product code HRN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLIRANS TE08 HOLLOW FIBER DIALYZER?

CLIRANS TE08 HOLLOW FIBER DIALYZER is a medical device that received FDA 510(k) clearance on 1983-01-08. The listed applicant is Terumo Medical Corp.. The 510(k) number is K823768.

When did CLIRANS TE08 HOLLOW FIBER DIALYZER receive FDA 510(k) clearance?

CLIRANS TE08 HOLLOW FIBER DIALYZER received FDA 510(k) clearance on 1983-01-08, under 510(k) number K823768.

Who is the listed applicant for CLIRANS TE08 HOLLOW FIBER DIALYZER?

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

What is the FDA product code for CLIRANS TE08 HOLLOW FIBER DIALYZER?

The FDA product code for CLIRANS TE08 HOLLOW FIBER DIALYZER is HRN.

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Related Devices (Code: HRN)

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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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