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510(k) Data Aggregation
K Number
K031681Device Name
STERISIL ANTIMICROBIAL TUBING AND BOTTLE
Manufacturer
Date Cleared
2003-10-30
(153 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
STERISIL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The treated article controls the growth of bacteria, fungus, and algae providing the antimicrobial surface is regenerated with the continuous use of a Sterisil water pre-treatment product. The Sterisil treated article is intended to be used with distilled, deionized, or reverse osmosis water. Efficacy for tap water has not been determined. This product is not intended to provide sterile water.
Device Description
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