The following data is part of a premarket notification filed by Medtronic Xomed with the FDA for Xps 3000 System.
| Device ID | K002224 |
| 510k Number | K002224 |
| Device Name: | XPS 3000 SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Martin D Sargent |
| Correspondent | Martin D Sargent MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-24 |
| Decision Date | 2000-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994921752 | K002224 | 000 |
| 00643169360846 | K002224 | 000 |
| 00643169350663 | K002224 | 000 |
| 20681490049133 | K002224 | 000 |
| 00721902773013 | K002224 | 000 |