BREATHE RIGHT

Dilator, Nasal

CNS, INC.

The following data is part of a premarket notification filed by Cns, Inc. with the FDA for Breathe Right.

Pre-market Notification Details

• Device ID: K921220
• 510k Number: K921220
• Device Name: BREATHE RIGHT
• Classification: Dilator, Nasal
• Applicant: CNS, INC. 1250 PARK RD. Chanhassen, MN 55317
• Contact: M.w. Anderson
• Correspondent: M.w. Anderson; CNS, INC. 1250 PARK RD. Chanhassen, MN 55317
• Product Code: LWF
• CFR Regulation Number: 874.3900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-03-13
• Decision Date: 1993-10-07