The following data is part of a premarket notification filed by Sordina S.p.a. with the FDA for Liac.
Device ID | K110840 |
510k Number | K110840 |
Device Name: | LIAC |
Classification | Accelerator, Linear, Medical |
Applicant | SORDINA S.P.A. 110 E. GRANADA BLVD SUITE 207 Ormond Beach, FL 32176 |
Contact | Berthoin Claude |
Correspondent | Berthoin Claude SORDINA S.P.A. 110 E. GRANADA BLVD SUITE 207 Ormond Beach, FL 32176 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-25 |
Decision Date | 2012-04-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LIAC 79147189 4710077 Live/Registered |
S.I.T. SORDINA IORT TECHNOLOGIES SPA 2013-12-17 |