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FDA 510(k)

FUJI II LC (IMPROVED)

K-Number: K961584 · 1996-05-24

ApplicantGC America, Inc.
Decision Date1996-05-24
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FUJI II LC (IMPROVED) 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 1996-05-24 under 510(k) number K961584. 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 (IMPROVED)?

FUJI II LC (IMPROVED) is a medical device that received FDA 510(k) clearance on 1996-05-24. The listed applicant is GC America, Inc.. The 510(k) number is K961584.

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

FUJI II LC (IMPROVED) received FDA 510(k) clearance on 1996-05-24, under 510(k) number K961584.

Who is the listed applicant for FUJI II LC (IMPROVED)?

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 FUJI II LC (IMPROVED)?

The FDA product code for FUJI II LC (IMPROVED) is EMA.

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Other records listing GC America, Inc. as applicant

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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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