The following data is part of a premarket notification filed by Leone Spa with the FDA for Leone Implant System.
Device ID | K050586 |
510k Number | K050586 |
Device Name: | LEONE IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | LEONE SPA 3722 AVE. SAUSALITO Irvine, CA 92606 |
Contact | Greg Holland |
Correspondent | Greg Holland LEONE SPA 3722 AVE. SAUSALITO Irvine, CA 92606 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-07 |
Decision Date | 2006-02-27 |
Summary: | summary |