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FDA 510(k)

CLEAFIL DC CORE AUTOMIX

K-Number: K043177 · 2004-12-17

ApplicantKuraray Medical, Inc.
Decision Date2004-12-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEAFIL DC CORE AUTOMIX 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 2004-12-17 under 510(k) number K043177. 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 CLEAFIL DC CORE AUTOMIX?

CLEAFIL DC CORE AUTOMIX is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K043177.

When did CLEAFIL DC CORE AUTOMIX receive FDA 510(k) clearance?

CLEAFIL DC CORE AUTOMIX received FDA 510(k) clearance on 2004-12-17, under 510(k) number K043177.

Who is the listed applicant for CLEAFIL DC CORE AUTOMIX?

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 CLEAFIL DC CORE AUTOMIX?

The FDA product code for CLEAFIL DC CORE AUTOMIX is EBF.

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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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