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510(k) Data Aggregation
K Number
K141504Device Name
T-8000 THEROZONE UNIT
Manufacturer
Date Cleared
2015-02-24
(263 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
THEROZONE USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines.
Device Description
The T-8000 TherOzone Unit is a device intended to clean dental unit water lines. The device consists of an ozone generator and dispensing bottles.
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