FUL-VUE

Refractor, Manual, Non-powered, Including Phoropter

AMERICAN OPTICAL CORP.

The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Ful-vue.

Pre-market Notification Details

• Device ID: K782118
• 510k Number: K782118
• Device Name: FUL-VUE
• Classification: Refractor, Manual, Non-powered, Including Phoropter
• Applicant: AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: HKN
• CFR Regulation Number: 886.1770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-12-27
• Decision Date: 1979-01-26