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FDA 510(k)

KROMATICA COLOR CHANGING ALGINATE

K-Number: K974894 · 1998-02-12

ApplicantMatech, Inc.
Decision Date1998-02-12
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KROMATICA COLOR CHANGING ALGINATE is the device name listed in this FDA 510(k) record. The listed applicant is Matech, Inc.. It received FDA 510(k) clearance on 1998-02-12 under 510(k) number K974894. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KROMATICA COLOR CHANGING ALGINATE?

KROMATICA COLOR CHANGING ALGINATE is a medical device that received FDA 510(k) clearance on 1998-02-12. The listed applicant is Matech, Inc.. The 510(k) number is K974894.

When did KROMATICA COLOR CHANGING ALGINATE receive FDA 510(k) clearance?

KROMATICA COLOR CHANGING ALGINATE received FDA 510(k) clearance on 1998-02-12, under 510(k) number K974894.

Who is the listed applicant for KROMATICA COLOR CHANGING ALGINATE?

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

What is the FDA product code for KROMATICA COLOR CHANGING ALGINATE?

The FDA product code for KROMATICA COLOR CHANGING ALGINATE is ELW.

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Other records listing Matech, Inc. as applicant

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Related Devices (Code: ELW)

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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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