The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Xps 3000 System.
| Device ID | K041523 |
| 510k Number | K041523 |
| Device Name: | XPS 3000 SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Martin D Sargent |
| Correspondent | Martin D Sargent MEDTRONIC XOMED, INC. 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 | 2004-06-08 |
| Decision Date | 2004-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169882713 | K041523 | 000 |
| 00885074107349 | K041523 | 000 |
| 00885074107332 | K041523 | 000 |