The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Frontal Sinus Trephination Cannula.
| Device ID | K994262 |
| 510k Number | K994262 |
| Device Name: | FRONTAL SINUS TREPHINATION CANNULA |
| Classification | Cannula, Sinus |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Martin D Sargent |
| Correspondent | Martin D Sargent 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 | 1999-12-17 |
| Decision Date | 2000-02-08 |
| Summary: | summary |