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FDA 510(k)

GTI CLASP COVER

K-Number: K913200 · 1992-02-03

ApplicantGti, Inc.
Decision Date1992-02-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GTI CLASP COVER is the device name listed in this FDA 510(k) record. The listed applicant is Gti, Inc.. It received FDA 510(k) clearance on 1992-02-03 under 510(k) number K913200. 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 GTI CLASP COVER?

GTI CLASP COVER is a medical device that received FDA 510(k) clearance on 1992-02-03. The listed applicant is Gti, Inc.. The 510(k) number is K913200.

When did GTI CLASP COVER receive FDA 510(k) clearance?

GTI CLASP COVER received FDA 510(k) clearance on 1992-02-03, under 510(k) number K913200.

Who is the listed applicant for GTI CLASP COVER?

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

What is the FDA product code for GTI CLASP COVER?

The FDA product code for GTI CLASP COVER is EBF.

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Other records listing Gti, 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.

K860347SUNLAMP MODELS 24N, 30R, 30RE, 37RE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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