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[Trade Name] silicone sheeting is indicated for management of hypertrophic scars and keloids. Consistent use of [Trade Name] can reduce hypertrophic scarring and keloid formation, resulting from surgical or traumatic injury of the skin. [Trade Name] may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.

[Trade Name] is a self-adhesive, fabric-backed, semi-disposable silicone sheet. The main component of the product is a proprietary material called Silon®. The basic Silon material is made from a blend of medical grade silicone and polytetrafluoroethylene ("PTFE") in the form of an interpenetrating polymer network. [Trade Name] is not sterile and does not contain antibiotics. [Trade Name] is not intended for use on open wounds. Each package of [Trade Name] contains 30 individual sheets (1.5" x 3"). Each sheet can be cut to fit the size of the scar or applied side-by-side, depending on the size of the scar.

This 510(k) submission does not contain information about acceptance criteria or a study demonstrating that the device meets such criteria. The document states "Performance Data: Not applicable" and primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and biocompatibility testing.

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