The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Rossiter Sinus Stent.
| Device ID | K951803 |
| 510k Number | K951803 |
| Device Name: | ROSSITER SINUS STENT |
| Classification | Cannula, Sinus |
| 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 | KAM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-19 |
| Decision Date | 1995-05-11 |