OPTISOL

Media, Corneal Storage

CHIRON OPHTHALMICS

The following data is part of a premarket notification filed by Chiron Ophthalmics with the FDA for Optisol.

Pre-market Notification Details

• Device ID: K894162
• 510k Number: K894162
• Device Name: OPTISOL
• Classification: Media, Corneal Storage
• Applicant: CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718
• Contact: Mcgarvey
• Correspondent: Mcgarvey; CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718
• 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: 1989-06-14
• Decision Date: 1990-01-12