# K991604: Epi-Foam Silicone Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: Biodermis Corp.
- Decided: Jun 9, 1999 after 30 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Epi-Foam Sheeting is intended for the management of hypertrophic and keloid scars. Epi-Foam is not intended for use on open wounds.

Source page: https://510kreport.com/device/K991604
Methodology: https://510kreport.com/methodology