The following data is part of a premarket notification filed by Al.chi.mi.a. S.r.l. with the FDA for Eusol-c.
Device ID | K162013 |
510k Number | K162013 |
Device Name: | Eusol-C |
Classification | Media, Corneal Storage |
Applicant | AL.CHI.MI.A. S.r.l. Viale Austria 14 Ponte San Nicolo, IT 35020 |
Contact | Mauro Beccaro |
Correspondent | Elena Morozova AL.CHI.MI.A. S.r.l. 1416 Obispo Ave. Coral Gables, FL 33134 |
Product Code | LYX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-21 |
Decision Date | 2016-09-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EUSOL-C 97613897 not registered Live/Pending |
Oftalone, Inc 2022-09-30 |