DYNAFLEX

Device, Anti-snoring

DYNAFLEX

The following data is part of a premarket notification filed by Dynaflex with the FDA for Dynaflex.

Pre-market Notification Details

• Device ID: K103076
• 510k Number: K103076
• Device Name: DYNAFLEX
• Classification: Device, Anti-snoring
• Applicant: DYNAFLEX 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701
• Contact: Stuart R Goldman
• Correspondent: Stuart R Goldman; DYNAFLEX 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701
• Product Code: LRK
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-10-18
• Decision Date: 2011-02-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D84101511W	K103076	000
D84101101R	K103076	000
D8410056G19	K103076	000