POLARON

Aid, Vision, Electronic, Battery-powered

NURION INDUSTRIES

The following data is part of a premarket notification filed by Nurion Industries with the FDA for Polaron.

Pre-market Notification Details

• Device ID: K902187
• 510k Number: K902187
• Device Name: POLARON
• Classification: Aid, Vision, Electronic, Battery-powered
• Applicant: NURION INDUSTRIES STATION SQUARE THREE Paoli, PA 19301
• Contact: William P Rosen
• Correspondent: William P Rosen; NURION INDUSTRIES STATION SQUARE THREE Paoli, PA 19301
• Product Code: HPG
• CFR Regulation Number: 886.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-05-14
• Decision Date: 1990-08-08