The following data is part of a premarket notification filed by Les Laboratorires Brothier, S.a. with the FDA for Entaxis Nasal Packing.
| Device ID | K984069 |
| 510k Number | K984069 |
| Device Name: | ENTAXIS NASAL PACKING |
| Classification | Balloon, Epistaxis |
| Applicant | LES LABORATORIRES BROTHIER, S.A. 7527 WESTMORELAND AVE. St Louis, MO 63105 |
| Contact | Evan Dick |
| Correspondent | Evan Dick LES LABORATORIRES BROTHIER, S.A. 7527 WESTMORELAND AVE. St Louis, MO 63105 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-16 |
| Decision Date | 1999-01-25 |
| Summary: | summary |