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FDA 510(k)

PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER

K-Number: K023662 · 2003-05-28

ApplicantHwadong International Company , Ltd.
Decision Date2003-05-28
Product CodeMCF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Hwadong International Company , Ltd.. It received FDA 510(k) clearance on 2003-05-28 under 510(k) number K023662. The device is classified under product code MCF. It was reviewed by the DE advisory panel. Product code MCF falls under the category of Surgical Instruments, which includes handheld instruments for general and specialized surgical procedures. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER?

PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER is a medical device that received FDA 510(k) clearance on 2003-05-28. The listed applicant is Hwadong International Company , Ltd.. The 510(k) number is K023662.

When did PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER receive FDA 510(k) clearance?

PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER received FDA 510(k) clearance on 2003-05-28, under 510(k) number K023662.

Who is the listed applicant for PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER?

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

What is the FDA product code for PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER?

The FDA product code for PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER is MCF. This falls under the Surgical Instruments category.

Related Clinical Trials

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: MCF)

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.

K021258GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZERGerm Terminator CorporationK003517OTRES TOOTHBRUSH SANITIZER MODEL TB100WOtres, LLCK901459DS60 TOOTHBRUSH SANITIZERAssociated Mills, Inc.K896481PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZERPurebrush Assoc.

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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