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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K200456
Device Name Becker External Drainage and Monitoring System
Applicant
Medtronic, Inc.
125 Cremona Drive
Goleta,  CA  93117
Applicant Contact Nancy Hampton
Correspondent
Medtronic, Inc.
125 Cremona Drive
Goleta,  CA  93117
Correspondent Contact Nancy Hampton
Regulation Number882.1620
Classification Product Code
GWM  
Date Received02/25/2020
Decision Date 03/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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