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FDA 510(k)

THE FUGO BLADE FOR DENTISTRY

K-Number: K063468 · 2007-04-18

ApplicantMedisurg , Ltd.
Decision Date2007-04-18
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE FUGO BLADE FOR DENTISTRY is the device name listed in this FDA 510(k) record. The listed applicant is Medisurg , Ltd.. It received FDA 510(k) clearance on 2007-04-18 under 510(k) number K063468. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE FUGO BLADE FOR DENTISTRY?

THE FUGO BLADE FOR DENTISTRY is a medical device that received FDA 510(k) clearance on 2007-04-18. The listed applicant is Medisurg , Ltd.. The 510(k) number is K063468.

When did THE FUGO BLADE FOR DENTISTRY receive FDA 510(k) clearance?

THE FUGO BLADE FOR DENTISTRY received FDA 510(k) clearance on 2007-04-18, under 510(k) number K063468.

Who is the listed applicant for THE FUGO BLADE FOR DENTISTRY?

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

What is the FDA product code for THE FUGO BLADE FOR DENTISTRY?

The FDA product code for THE FUGO BLADE FOR DENTISTRY is EKZ.

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Other records listing Medisurg , Ltd. 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.

K050933FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300K041019THE FUGO BLADE FOR GLAUCOMAK001498THE FUGO BLADE

Related Devices (Code: EKZ)

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.

K213477Root ZX3J. Morita USA, Inc.K071632PERFECT TISSUE CONTOURING SYSTEM IIColtene/Whaledent, Inc.K052622MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITMacan Engineering Co.K050735MC6AMacan Engineering Co.K023672X O ODONTOSURGE 4Xo Care A/SK020080BONART ART-E1 ELECTROSURGERY UNITDiagnostic Data, 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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