EPI-DERM SILICONE GEL SHEETING

• K Number: K003948
• Device Name: EPI-DERM SILICONE GEL SHEETING
• Manufacturer: BIODERMIS CORP.
• Date Cleared: 2001-01-29 ( 39 days)
• Product Code: MDA
• Regulation Number: 878.4025
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 878.4025 Silicone sheeting.

(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.