The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Ent Rf System.
| Device ID | K993112 |
| 510k Number | K993112 |
| Device Name: | XOMED ENT RF SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-17 |
| Decision Date | 1999-12-09 |
| Summary: | summary |