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 |