MULTI

Sunglasses (non-prescription Including Photosensitive)

MORNING CALM CORP.

The following data is part of a premarket notification filed by Morning Calm Corp. with the FDA for Multi.

Pre-market Notification Details

• Device ID: K974414
• 510k Number: K974414
• Device Name: MULTI
• Classification: Sunglasses (non-prescription Including Photosensitive)
• Applicant: MORNING CALM CORP. 1106 SEONG AN OFFICETEL 87-36, DURYU-2DONG,DALSEO-GU Daegu, KP
• Contact: Alexander B Kim
• Correspondent: Alexander B Kim; MORNING CALM CORP. 1106 SEONG AN OFFICETEL 87-36, DURYU-2DONG,DALSEO-GU Daegu, KP
• Product Code: HQY
• CFR Regulation Number: 886.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-11-24
• Decision Date: 1997-12-08