The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed T-stent, Frontal Sinus Stent.
| Device ID | K973273 |
| 510k Number | K973273 |
| Device Name: | XOMED T-STENT, FRONTAL SINUS STENT |
| Classification | Cannula, Sinus |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Debra B Cortner |
| Correspondent | Debra B Cortner XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | KAM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1997-09-29 |
| Summary: | summary |