XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

MEDTRONIC XOMED, INC.

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).

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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