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FDA 510(k)

FUJI II LC

K-Number: K913884 · 1991-10-30

ApplicantG-C Intl. Corp.
Decision Date1991-10-30
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FUJI II LC is the device name listed in this FDA 510(k) record. The listed applicant is G-C Intl. Corp.. It received FDA 510(k) clearance on 1991-10-30 under 510(k) number K913884. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI II LC?

FUJI II LC is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is G-C Intl. Corp.. The 510(k) number is K913884.

When did FUJI II LC receive FDA 510(k) clearance?

FUJI II LC received FDA 510(k) clearance on 1991-10-30, under 510(k) number K913884.

Who is the listed applicant for FUJI II LC?

The FDA 510(k) record lists G-C Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJI II LC?

The FDA product code for FUJI II LC is EMA.

Other records listing G-C Intl. Corp. as applicant

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.

K913175MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULESK901999FUJI LINING CEMENT LIGHT CUREK902531EXAPHASE, SINGLE PHASE IMPRESSION MATERIALK896883GC CERVICAL CEMENTK895976TOOTH SHADE RESINK892806TUF-COAT

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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