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FDA 510(k)

Custodiol HTK Solution

K-Number: K192408 · 2020-04-24

ApplicantDr. Franz Kohler Chemie GmbH
Decision Date2020-04-24
Product CodeKDL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Custodiol HTK Solution is a medical device manufactured by Dr. Franz Kohler Chemie GmbH. It received FDA 510(k) clearance on 2020-04-24 under approval number K192408. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Custodiol HTK Solution?

Custodiol HTK Solution is a medical device that received FDA 510(k) clearance on 2020-04-24. It is manufactured by Dr. Franz Kohler Chemie GmbH. The 510(k) number is K192408.

When was Custodiol HTK Solution approved by the FDA?

Custodiol HTK Solution received FDA 510(k) clearance on 2020-04-24, under approval number K192408.

What company makes Custodiol HTK Solution?

Custodiol HTK Solution is manufactured by Dr. Franz Kohler Chemie GmbH.

What is the FDA product code for Custodiol HTK Solution?

The FDA product code for Custodiol HTK Solution is KDL.

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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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