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FDA 510(k)

UNI-THANE

K-Number: K812448 · 1981-10-02

ApplicantUnicare Systems, Inc.
Decision Date1981-10-02
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNI-THANE is the device name listed in this FDA 510(k) record. The listed applicant is Unicare Systems, Inc.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812448. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-THANE?

UNI-THANE is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Unicare Systems, Inc.. The 510(k) number is K812448.

When did UNI-THANE receive FDA 510(k) clearance?

UNI-THANE received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812448.

Who is the listed applicant for UNI-THANE?

The FDA 510(k) record lists Unicare Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNI-THANE?

The FDA product code for UNI-THANE is KKX.

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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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