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FDA 510(k)

MI FLOW (GCUC-450)

K-Number: K090747 · 2009-06-10

ApplicantGC America, Inc.
Decision Date2009-06-10
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MI FLOW (GCUC-450) 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 2009-06-10 under 510(k) number K090747. 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 MI FLOW (GCUC-450)?

MI FLOW (GCUC-450) is a medical device that received FDA 510(k) clearance on 2009-06-10. The listed applicant is GC America, Inc.. The 510(k) number is K090747.

When did MI FLOW (GCUC-450) receive FDA 510(k) clearance?

MI FLOW (GCUC-450) received FDA 510(k) clearance on 2009-06-10, under 510(k) number K090747.

Who is the listed applicant for MI FLOW (GCUC-450)?

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 MI FLOW (GCUC-450)?

The FDA product code for MI FLOW (GCUC-450) is EBF.

Other records listing GC America, Inc. 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.

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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