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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 K000057
Device Name RADIONICS LUMBOPERITONEAL SHUNT
Applicant
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2516
Applicant Contact KEVIN K O'CONNELL
Correspondent
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2516
Correspondent Contact KEVIN K O'CONNELL
Regulation Number882.5550
Classification Product Code
JXG  
Date Received01/10/2000
Decision Date 03/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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