Dayspring

Sleeve, Limb, Compressible

Koya Medical, Inc.

The following data is part of a premarket notification filed by Koya Medical, Inc. with the FDA for Dayspring.

Pre-market Notification Details

• Device ID: K210885
• 510k Number: K210885
• Device Name: Dayspring
• Classification: Sleeve, Limb, Compressible
• Applicant: Koya Medical, Inc. 2461 Peralta St. Oakland, CA 94607
• Contact: Andy Doraiswamy
• Correspondent: Alex Chang; BioDesign Regulatory Services, LLC 16185 Los Gatos Blvd. Los Gatos, CA 95032
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-03-25
• Decision Date: 2021-04-23