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510(k) Data Aggregation
K Number
K980842Device Name
COPPER TONGUE SCRAPER
Manufacturer
ONTEL PRODUCTS CORP.
Date Cleared
1998-05-20
(77 days)
Product Code
LCN
Regulation Number
872.6855Why did this record match?
Applicant Name (Manufacturer) :
ONTEL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Copper Tongue Scraper's intend use is to remove bacteria and food debris from the tongue surface, hence promoting good oral hygiene. It is intended for over-the-counter point of sale as are other predicate devices.
Device Description
This device is a U-formed design made of Copper.
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