CLASSIC MATCH

Sunglasses (non-prescription Including Photosensitive)

DELAGAR DIVISION BELCAM, INC.

The following data is part of a premarket notification filed by Delagar Division Belcam, Inc. with the FDA for Classic Match.

Pre-market Notification Details

• Device ID: K971104
• 510k Number: K971104
• Device Name: CLASSIC MATCH
• Classification: Sunglasses (non-prescription Including Photosensitive)
• Applicant: DELAGAR DIVISION BELCAM, INC. 27 MONTGOMERY ST. Rouses Point, NY 12979 -0277
• Contact: Cally Lunetta
• Correspondent: Cally Lunetta; DELAGAR DIVISION BELCAM, INC. 27 MONTGOMERY ST. Rouses Point, NY 12979 -0277
• Product Code: HQY
• CFR Regulation Number: 886.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-03-26
• Decision Date: 1997-05-06