The following data is part of a premarket notification filed by Cambridge Assoc. with the FDA for Breathe Fit.
| Device ID | K963326 |
| 510k Number | K963326 |
| Device Name: | BREATHE FIT |
| Classification | Dilator, Nasal |
| Applicant | CAMBRIDGE ASSOC. 15 OAK ST. Beverly Farms, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White CAMBRIDGE ASSOC. 15 OAK ST. Beverly Farms, MA 01915 |
| Product Code | LWF |
| CFR Regulation Number | 874.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-23 |
| Decision Date | 1997-02-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BREATHE FIT 74684792 not registered Dead/Abandoned |
Cambridge Associates 1995-06-05 |