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FDA 510(k)

BISCEM GI

K-Number: K032597 · 2003-11-04

ApplicantBisco, Inc.
Decision Date2003-11-04
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BISCEM GI is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2003-11-04 under 510(k) number K032597. 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 BISCEM GI?

BISCEM GI is a medical device that received FDA 510(k) clearance on 2003-11-04. The listed applicant is Bisco, Inc.. The 510(k) number is K032597.

When did BISCEM GI receive FDA 510(k) clearance?

BISCEM GI received FDA 510(k) clearance on 2003-11-04, under 510(k) number K032597.

Who is the listed applicant for BISCEM GI?

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

What is the FDA product code for BISCEM GI?

The FDA product code for BISCEM GI is EMA.

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Other records listing Bisco, 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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