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FDA 510(k)

EZEE FILTER/SEPARATOR

K-Number: K831081 · 1983-05-16

ApplicantThe Kendall Company Div. of Tyco Healthcare Group
Decision Date1983-05-16
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EZEE FILTER/SEPARATOR is the device name listed in this FDA 510(k) record. The listed applicant is The Kendall Company Div. of Tyco Healthcare Group. It received FDA 510(k) clearance on 1983-05-16 under 510(k) number K831081. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZEE FILTER/SEPARATOR?

EZEE FILTER/SEPARATOR is a medical device that received FDA 510(k) clearance on 1983-05-16. The listed applicant is The Kendall Company Div. of Tyco Healthcare Group. The 510(k) number is K831081.

When did EZEE FILTER/SEPARATOR receive FDA 510(k) clearance?

EZEE FILTER/SEPARATOR received FDA 510(k) clearance on 1983-05-16, under 510(k) number K831081.

Who is the listed applicant for EZEE FILTER/SEPARATOR?

The FDA 510(k) record lists The Kendall Company Div. of Tyco Healthcare Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZEE FILTER/SEPARATOR?

The FDA product code for EZEE FILTER/SEPARATOR is JKA.

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Other records listing The Kendall Company Div. of Tyco Healthcare Group as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JKA)

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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.

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