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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K013000
Device Name MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
Applicant
Medtronic Neurosurgery
125 Cremona Dr.
Goleta,  CA  93117
Applicant Contact JANET MCAULEY
Correspondent
Medtronic Neurosurgery
125 Cremona Dr.
Goleta,  CA  93117
Correspondent Contact JANET MCAULEY
Regulation Number882.5330
Classification Product Code
GXN  
Date Received09/06/2001
Decision Date 12/05/2001
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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