SUNSATION

Booth, Sun Tan

FASHION, INC.

The following data is part of a premarket notification filed by Fashion, Inc. with the FDA for Sunsation.

Pre-market Notification Details

• Device ID: K801429
• 510k Number: K801429
• Device Name: SUNSATION
• Classification: Booth, Sun Tan
• Applicant: FASHION, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: LEJ
• CFR Regulation Number: 878.4635 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-06-17
• Decision Date: 1980-07-28