510(k) K121824
K121824 is an FDA 510(k) premarket notification submitted by Lascod Spa for the device "ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2". The FDA issued a decision of Substantially Equivalent on Aug 23, 2012. 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
- Aug 23, 2012
- Date Received
- Jun 21, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type
- 510(k)