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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K152342
Device Name Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
Applicant
St Jude Medical
6901 Preston Rd.
Plano,  TX  75024
Applicant Contact PARITA MEHTA
Correspondent
St Jude Medical
15900 Valley View Court
Sylamr,  CA  91342
Correspondent Contact Manasi Khare
Regulation Number882.5250
Classification Product Code
GXR  
Date Received08/19/2015
Decision Date 06/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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