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FDA 510(k)

CHROMA ZONE COLOR STAIN

K-Number: K982259 · 1998-09-22

ApplicantKuraray America, Inc.
Decision Date1998-09-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHROMA ZONE COLOR STAIN is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray America, Inc.. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K982259. 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 CHROMA ZONE COLOR STAIN?

CHROMA ZONE COLOR STAIN is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Kuraray America, Inc.. The 510(k) number is K982259.

When did CHROMA ZONE COLOR STAIN receive FDA 510(k) clearance?

CHROMA ZONE COLOR STAIN received FDA 510(k) clearance on 1998-09-22, under 510(k) number K982259.

Who is the listed applicant for CHROMA ZONE COLOR STAIN?

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

What is the FDA product code for CHROMA ZONE COLOR STAIN?

The FDA product code for CHROMA ZONE COLOR STAIN is EBF.

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Other records listing Kuraray America, Inc. as applicant

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Related Devices (Code: 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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