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FDA 510(k)

K-FREE

K-Number: K912587 · 1991-07-30

ApplicantKatecho, Inc.
Decision Date1991-07-30
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

K-FREE is the device name listed in this FDA 510(k) record. The listed applicant is Katecho, Inc.. It received FDA 510(k) clearance on 1991-07-30 under 510(k) number K912587. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-FREE?

K-FREE is a medical device that received FDA 510(k) clearance on 1991-07-30. The listed applicant is Katecho, Inc.. The 510(k) number is K912587.

When did K-FREE receive FDA 510(k) clearance?

K-FREE received FDA 510(k) clearance on 1991-07-30, under 510(k) number K912587.

Who is the listed applicant for K-FREE?

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

What is the FDA product code for K-FREE?

The FDA product code for K-FREE is LDD.

Other records listing Katecho, Inc. 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: LDD)

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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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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