The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Epistaxis Nasal Balloon Catheter.
| Device ID | K921199 |
| 510k Number | K921199 |
| Device Name: | EPISTAXIS NASAL BALLOON CATHETER |
| Classification | Balloon, Epistaxis |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas Craig |
| Correspondent | Thomas Craig SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-12 |
| Decision Date | 1992-07-08 |