UNISUN

Sunglasses (non-prescription Including Photosensitive)

STEVEN CHEN

The following data is part of a premarket notification filed by Steven Chen with the FDA for Unisun.

Pre-market Notification Details

• Device ID: K955539
• 510k Number: K955539
• Device Name: UNISUN
• Classification: Sunglasses (non-prescription Including Photosensitive)
• Applicant: STEVEN CHEN 5400 E. 21ST ST. #616 Wichita, KS 67208
• Contact: Steven Chen
• Correspondent: Steven Chen; STEVEN CHEN 5400 E. 21ST ST. #616 Wichita, KS 67208
• Product Code: HQY
• CFR Regulation Number: 886.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-12-05
• Decision Date: 1996-01-03