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510(k) Data Aggregation
K Number
K053625Device Name
NASALGUARD
Manufacturer
TRUTEK CORP
Date Cleared
2006-02-22
(56 days)
Product Code
NUP
Regulation Number
880.5045Why did this record match?
Applicant Name (Manufacturer) :
TRUTEK CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NasalGuard® is intended to promote alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny or congested nasal passages) triggered by the inhalation of various allergens including environmental pollens, house dust, animal hairs and dust mites.
Device Description
NasalGuard is a water-based gel consisting of common, GRAS cosmetic grade ingredients. The product is applied by finger or cotton swab to the outside of the nasal passages, around the nostrils and upper lip. NasalGuard utilizes a patented methodology that uses the cationic properties of its ingredients to create an electrostatic field that attracts and blocks airborne allergens before they enter the nasal passages. The gel is considered innocuous and does not penetrate the dermal layer of the skin. The gel is concentrated and lasts for 4-6 hours before the gel has to be reapplied. NasalGuard is intended for topical use and provided non-sterile.
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