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510(k) K150728

XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole by Medtronic Xomed, Inc. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2015
Date Received
March 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

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