EUSOL-C

Media, Corneal Storage

AL.CHI.MI.A

The following data is part of a premarket notification filed by Al.chi.mi.a with the FDA for Eusol-c.

Pre-market Notification Details

• Device ID: K032422
• 510k Number: K032422
• Device Name: EUSOL-C
• Classification: Media, Corneal Storage
• Applicant: AL.CHI.MI.A 377 ROUTE 17 S Hasbrouck Heights, NJ 07604
• Contact: George Myers
• Correspondent: George Myers; AL.CHI.MI.A 377 ROUTE 17 S Hasbrouck Heights, NJ 07604
• Product Code: LYX
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-05
• Decision Date: 2003-12-15
• Summary: summary