The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xps Tissue Aspiration System, Xps Straightshot Or Model 2000 Microdebrider System.
| Device ID | K984363 |
| 510k Number | K984363 |
| Device Name: | XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | David Timlin |
| Correspondent | David Timlin XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-07 |
| Decision Date | 1999-02-26 |
| Summary: | summary |