Decision Date1983-11-15
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ASAHI HOLLOW FIBER KIDNEYS, EXCEL is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Medical Co., Ltd.. It received FDA 510(k) clearance on 1983-11-15 under 510(k) number K833150. 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, EXCEL?
ASAHI HOLLOW FIBER KIDNEYS, EXCEL is a medical device that received FDA 510(k) clearance on 1983-11-15. The listed applicant is Asahi Medical Co., Ltd.. The 510(k) number is K833150.
When did ASAHI HOLLOW FIBER KIDNEYS, EXCEL receive FDA 510(k) clearance?
ASAHI HOLLOW FIBER KIDNEYS, EXCEL received FDA 510(k) clearance on 1983-11-15, under 510(k) number K833150.
Who is the listed applicant for ASAHI HOLLOW FIBER KIDNEYS, EXCEL?
The FDA 510(k) record lists Asahi Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ASAHI HOLLOW FIBER KIDNEYS, EXCEL?
The FDA product code for ASAHI HOLLOW FIBER KIDNEYS, EXCEL 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.