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FDA 510(k)

ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES

K-Number: K830231 · 1983-03-17

ApplicantAdvocacy International, Ltd.
Decision Date1983-03-17
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Advocacy International, Ltd.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K830231. 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 ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES?

ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Advocacy International, Ltd.. The 510(k) number is K830231.

When did ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES receive FDA 510(k) clearance?

ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES received FDA 510(k) clearance on 1983-03-17, under 510(k) number K830231.

Who is the listed applicant for ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES?

The FDA 510(k) record lists Advocacy International, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES?

The FDA product code for ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES 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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