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FDA 510(k)

HOLLOW FIBER DIALYZERS

K-Number: K840845 · 1984-08-16

ApplicantTravenol Laboratories, S.A.
Decision Date1984-08-16
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLOW FIBER DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1984-08-16 under 510(k) number K840845. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLLOW FIBER DIALYZERS?

HOLLOW FIBER DIALYZERS is a medical device that received FDA 510(k) clearance on 1984-08-16. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K840845.

When did HOLLOW FIBER DIALYZERS receive FDA 510(k) clearance?

HOLLOW FIBER DIALYZERS received FDA 510(k) clearance on 1984-08-16, under 510(k) number K840845.

Who is the listed applicant for HOLLOW FIBER DIALYZERS?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLLOW FIBER DIALYZERS?

The FDA product code for HOLLOW FIBER DIALYZERS is KOC.

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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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