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FDA 510(k)

GAMMA STERILIZED CAPILLARY FLOW DIALYZ

K-Number: K823778 · 1983-01-07

ApplicantTravenol Laboratories, S.A.
Decision Date1983-01-07
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMMA STERILIZED CAPILLARY FLOW DIALYZ 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 1983-01-07 under 510(k) number K823778. 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 GAMMA STERILIZED CAPILLARY FLOW DIALYZ?

GAMMA STERILIZED CAPILLARY FLOW DIALYZ is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K823778.

When did GAMMA STERILIZED CAPILLARY FLOW DIALYZ receive FDA 510(k) clearance?

GAMMA STERILIZED CAPILLARY FLOW DIALYZ received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823778.

Who is the listed applicant for GAMMA STERILIZED CAPILLARY FLOW DIALYZ?

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 GAMMA STERILIZED CAPILLARY FLOW DIALYZ?

The FDA product code for GAMMA STERILIZED CAPILLARY FLOW DIALYZ is KOC.

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Related Devices (Code: 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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