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FDA 510(k)

GC INITIAL MC, AL AND LF

K-Number: K040567 · 2004-04-22

ApplicantGC America, Inc.
Decision Date2004-04-22
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC INITIAL MC, AL AND LF is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2004-04-22 under 510(k) number K040567. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC INITIAL MC, AL AND LF?

GC INITIAL MC, AL AND LF is a medical device that received FDA 510(k) clearance on 2004-04-22. The listed applicant is GC America, Inc.. The 510(k) number is K040567.

When did GC INITIAL MC, AL AND LF receive FDA 510(k) clearance?

GC INITIAL MC, AL AND LF received FDA 510(k) clearance on 2004-04-22, under 510(k) number K040567.

Who is the listed applicant for GC INITIAL MC, AL AND LF?

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

What is the FDA product code for GC INITIAL MC, AL AND LF?

The FDA product code for GC INITIAL MC, AL AND LF is EIH.

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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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