510(k) K201184
K201184 is an FDA 510(k) premarket notification submitted by Lascod Spa for the device "Lascod Impression Materials". The FDA issued a decision of Substantially Equivalent on May 5, 2020. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Lascod Spa has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2020
- Date Received
- May 1, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type
- 510(k)