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510(k) K200630

Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags by Medtronic, Inc. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2020
Date Received
March 10, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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