The following data is part of a premarket notification filed by Lascod Spa with the FDA for Lascod Impression Materials.
| Device ID | K201184 |
| 510k Number | K201184 |
| Device Name: | Lascod Impression Materials |
| Classification | Material, Impression |
| Applicant | Lascod Spa Via Longo, 18 Sesto Fiorentino, IT 50019 |
| Contact | Gualtiero Cozzi |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2020-05-05 |