The following data is part of a premarket notification filed by Medisil Corporation with the FDA for Medisil Silicone Sheeting.
| Device ID | K040042 |
| 510k Number | K040042 |
| Device Name: | MEDISIL SILICONE SHEETING |
| Classification | Elastomer, Silicone Block |
| Applicant | MEDISIL CORPORATION 1735 N. OLIVE STREET Ventura, CA 93001 |
| Contact | Alastair Winn |
| Correspondent | Alastair Winn MEDISIL CORPORATION 1735 N. OLIVE STREET Ventura, CA 93001 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-12 |
| Decision Date | 2004-04-01 |