PURESLEEP

Device, Anti-snoring

SLEEP SCIENCE PARTNERS, INC.

The following data is part of a premarket notification filed by Sleep Science Partners, Inc. with the FDA for Puresleep.

Pre-market Notification Details

• Device ID: K113022
• 510k Number: K113022
• Device Name: PURESLEEP
• Classification: Device, Anti-snoring
• Applicant: SLEEP SCIENCE PARTNERS, INC. 900 Larkspur Landing Circle Suite 207 Larkspur, CA 94939
• Contact: Heather Flick
• Correspondent: Heather Flick; SLEEP SCIENCE PARTNERS, INC. 900 Larkspur Landing Circle Suite 207 Larkspur, CA 94939
• Product Code: LRK
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-11
• Decision Date: 2012-06-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851727004037	K113022	000