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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drills, burrs, trephines & accessories (simple, powered)
510(k) Number K111520
FOIA Releasable 510(k) K111520
Device Name IPC POWEREASE SYSTEM
Applicant
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Applicant Contact RISHI SINHA
Correspondent
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Correspondent Contact RISHI SINHA
Regulation Number882.4310
Classification Product Code
HBE  
Subsequent Product Codes
GWF   HWE  
Date Received06/02/2011
Decision Date 10/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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