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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 -2516
Applicant Contact KEVIN J O'CONNELL
Correspondent
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
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
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