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510(k) Data Aggregation
K Number
K091133Device Name
APLION TOPICAL CARE SYSTEM
Manufacturer
APLION MEDICAL,LLC
Date Cleared
2009-05-20
(30 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Applicant Name (Manufacturer) :
APLION MEDICAL,LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.
Device Description
An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gasses such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing (21 CFR 878.4020).
The Aplion Topical Care System ("Aplion System") consists of an occlusive wound dressing, a tubeset connection, and a small fluid-delivery component.
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