The following data is part of a premarket notification filed by Biodermis Corp. with the FDA for Epi-derm Silicone Gel Sheeting.
| Device ID | K942156 |
| 510k Number | K942156 |
| Device Name: | EPI-DERM SILICONE GEL SHEETING |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | BIODERMIS CORP. 3753 HOWARD HUGHES PARKWAY, SUITE #200 Las Vegas, NV 89109 |
| Contact | Dennis A Repella, Ph.d |
| Correspondent | Dennis A Repella, Ph.d BIODERMIS CORP. 3753 HOWARD HUGHES PARKWAY, SUITE #200 Las Vegas, NV 89109 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-03 |
| Decision Date | 1994-06-13 |