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510(k) Data Aggregation

K Number

Device Name

OOLI-U(TONGUE SCRAPER)

Manufacturer

TELEFAX INTL.

Date Cleared

1997-03-14

(67 days)

Product Code

LCN

Regulation Number

872.6855

Why did this record match?

Applicant Name (Manufacturer) :

TELEFAX INTL.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The device is intended to remove plaque and food debris from the surface of the tongue.

Device Description

The device is a formed piece of stainless steel.

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