The following data is part of a premarket notification filed by Lascod Spa with the FDA for Alginor Alginelle Type 1 And 2 Millenium Kromopan 1 And 2.
Device ID | K121824 |
510k Number | K121824 |
Device Name: | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 |
Classification | Material, Impression |
Applicant | LASCOD SPA 2600 MULLININIX MILL ROAD Mt. Airy, MD 21771 |
Contact | Blix Winston |
Correspondent | Blix Winston LASCOD SPA 2600 MULLININIX MILL ROAD Mt. Airy, MD 21771 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-21 |
Decision Date | 2012-08-23 |
Summary: | summary |