CRYSTAL

Sunglasses (non-prescription Including Photosensitive)

CRYSTAL OPTICAL CO., LTD.

The following data is part of a premarket notification filed by Crystal Optical Co., Ltd. with the FDA for Crystal.

Pre-market Notification Details

• Device ID: K951168
• 510k Number: K951168
• Device Name: CRYSTAL
• Classification: Sunglasses (non-prescription Including Photosensitive)
• Applicant: CRYSTAL OPTICAL CO., LTD. 10 FL., NO 56, LANE 452 DA-YE ROAD Taipei, TW
• Contact: Yung-chi Hsu
• Correspondent: Yung-chi Hsu; CRYSTAL OPTICAL CO., LTD. 10 FL., NO 56, LANE 452 DA-YE ROAD Taipei, TW
• Product Code: HQY
• CFR Regulation Number: 886.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-03-15
• Decision Date: 1995-05-12