FDA 510(k)

DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095

K-Number: K896006 · 1989-12-27

Decision Date1989-12-27

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K896006. 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 DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095?

DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095 is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K896006.

When did DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095 receive FDA 510(k) clearance?

DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095 received FDA 510(k) clearance on 1989-12-27, under 510(k) number K896006.

Who is the listed applicant for DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095?

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

What is the FDA product code for DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095?

The FDA product code for DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095 is KOC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.