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FDA 510(k)

K-ETCHANT GEL

K-Number: K062409 · 2006-11-08

ApplicantKuraray Medical, Inc.
Decision Date2006-11-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

K-ETCHANT GEL is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Medical, Inc.. It received FDA 510(k) clearance on 2006-11-08 under 510(k) number K062409. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ETCHANT GEL?

K-ETCHANT GEL is a medical device that received FDA 510(k) clearance on 2006-11-08. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K062409.

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

K-ETCHANT GEL received FDA 510(k) clearance on 2006-11-08, under 510(k) number K062409.

Who is the listed applicant for K-ETCHANT GEL?

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

What is the FDA product code for K-ETCHANT GEL?

The FDA product code for K-ETCHANT GEL is EBF.

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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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