The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Cons0le (ipc).
| Device ID | K081277 |
| 510k Number | K081277 |
| Device Name: | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Antoine Kouchakjy |
| Correspondent | Antoine Kouchakjy 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 | 2008-05-05 |
| Decision Date | 2008-09-05 |
| Summary: | summary |