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510(k) Data Aggregation
K Number
K001003Device Name
Z-NET
Manufacturer
DEMITE LIMITED
Date Cleared
2001-12-10
(621 days)
Product Code
FMW
Regulation Number
880.6190Why did this record match?
Applicant Name (Manufacturer) :
DEMITE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Z-Net reduces for up to 15 months house dust mites and their allergens in bedding, a leading cause of allergenic rhinitis, allergenic asthma, and allergenic eczema. Reductions are based on comparisons with untreated bed covers.
Device Description
The Z-Net allergy control device consists of a mattress cover and pillow cover created from polyester impregnated with permethrin. The treated fabric reduces the levels of house dust mites (HDM) and their allergens in the mattress and pillow which, in turn, provides relief to individuals suffering from atopic allergies.
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