The following data is part of a premarket notification filed by Cns, Inc. with the FDA for Breathe Right Nasal Strip.
| Device ID | K955711 |
| 510k Number | K955711 |
| Device Name: | BREATHE RIGHT NASAL STRIP |
| Classification | Dilator, Nasal |
| Applicant | CNS, INC. P.O. BOX 39802 Minneapolis, MN 55439 -0802 |
| Contact | M.w. (andy) Anderson |
| Correspondent | M.w. (andy) Anderson CNS, INC. P.O. BOX 39802 Minneapolis, MN 55439 -0802 |
| Product Code | LWF |
| CFR Regulation Number | 874.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-18 |
| Decision Date | 1996-05-30 |