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FDA 510(k)

CLEARFIL AP-X PLT INTRO KIT

K-Number: K022999 · 2002-10-24

ApplicantKuraray Medical, Inc.
Decision Date2002-10-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL AP-X PLT INTRO KIT 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 2002-10-24 under 510(k) number K022999. 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 CLEARFIL AP-X PLT INTRO KIT?

CLEARFIL AP-X PLT INTRO KIT is a medical device that received FDA 510(k) clearance on 2002-10-24. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K022999.

When did CLEARFIL AP-X PLT INTRO KIT receive FDA 510(k) clearance?

CLEARFIL AP-X PLT INTRO KIT received FDA 510(k) clearance on 2002-10-24, under 510(k) number K022999.

Who is the listed applicant for CLEARFIL AP-X PLT INTRO KIT?

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 CLEARFIL AP-X PLT INTRO KIT?

The FDA product code for CLEARFIL AP-X PLT INTRO KIT is EBF.

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Related Devices (Code: EBF)

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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