The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Hydrocell Nasal And Sinus Packs.
| Device ID | K954491 |
| 510k Number | K954491 |
| Device Name: | HYDROCELL NASAL AND SINUS PACKS |
| Classification | Balloon, Epistaxis |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Ronald K Smith |
| Correspondent | Ronald K Smith SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-27 |
| Decision Date | 1995-11-15 |