LENS

Device, Irrigation, Ocular Surgery

MORTAN, INC.

The following data is part of a premarket notification filed by Mortan, Inc. with the FDA for Lens.

Pre-market Notification Details

• Device ID: K821897
• 510k Number: K821897
• Device Name: LENS
• Classification: Device, Irrigation, Ocular Surgery
• Applicant: MORTAN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KYG
• CFR Regulation Number: 886.4360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-06-28
• Decision Date: 1983-01-05