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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K992226
Device Name XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
Applicant
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact KEVIN J O'CONNELL
Correspondent
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact KEVIN J O'CONNELL
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/02/1999
Decision Date 08/04/2000
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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