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510(k) Data Aggregation
K Number
K120059Device Name
LIQUID BANDAGE
Manufacturer
CHESSON LABORATORY ASSOCIATES, INC.
Date Cleared
2012-05-17
(129 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
CHESSON LABORATORY ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
[The device] is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. [The device] coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture.
Device Description
This product for nail dystrophy is a biocompatible, polymeric lacquer that is applied directly to the nail. The product is dispersed in a solution that dries rapidly, adhering to the contours of the nail to form a transparent, colorless, flexible, waterproof barrier.
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K Number
K083913Device Name
CHESSON LABS LIQUID BANDAGE
Manufacturer
CHESSON LABORATORY ASSOCIATES, INC.
Date Cleared
2009-07-31
(213 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
CHESSON LABORATORY ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To cover intact skin or minor cuts, scrapes, burns, and irritations of the skin, to help keep them clean and dry and help protect them from infection
Device Description
This product is a liguid polymer in a spray format. The solution is topically applied to the affected area and the carrier solvent evaporates allowing polymerization of the remaining constituents to form a non-toxic, hydrophobic, elastomeric polymer coating that provides a barner against moisture but that is permeable to oxygen. The intended use is as a liquid bandage, as this coating is biocompatible and forms a tough yet pliable seal, preventing it from cracking and peeling as the skin heals.
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