The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xps Drill System.
| Device ID | K983224 |
| 510k Number | K983224 |
| Device Name: | XPS DRILL SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| 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 | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-14 |
| Decision Date | 1998-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169955646 | K983224 | 000 |
| 00643169955639 | K983224 | 000 |
| 00763000009489 | K983224 | 000 |
| 00885074107370 | K983224 | 000 |
| 00885074107363 | K983224 | 000 |
| 00885074107356 | K983224 | 000 |