UNIKA

Sunglasses (non-prescription Including Photosensitive)

EYEWEAR PARTNERS CO.

The following data is part of a premarket notification filed by Eyewear Partners Co. with the FDA for Unika.

Pre-market Notification Details

• Device ID: K971327
• 510k Number: K971327
• Device Name: UNIKA
• Classification: Sunglasses (non-prescription Including Photosensitive)
• Applicant: EYEWEAR PARTNERS CO. 2 NORTHEAST 40TH ST. SUITE 202 Miami, FL 33137
• Contact: Murray Leibson
• Correspondent: Murray Leibson; EYEWEAR PARTNERS CO. 2 NORTHEAST 40TH ST. SUITE 202 Miami, FL 33137
• Product Code: HQY
• CFR Regulation Number: 886.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-04-10
• Decision Date: 1997-05-09