The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Xps Curved Bur.
| Device ID | K041985 |
| 510k Number | K041985 |
| Device Name: | XPS CURVED BUR |
| Classification | Bur, Ear, Nose And Throat |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Martin D Sargent |
| Correspondent | William J Sammons UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | EQJ |
| CFR Regulation Number | 874.4140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-07-23 |
| Decision Date | 2004-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994223470 | K041985 | 000 |
| 00613994223463 | K041985 | 000 |
| 00613994223449 | K041985 | 000 |
| 00613994223425 | K041985 | 000 |
| 00613994223418 | K041985 | 000 |