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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 K971511
Device Name RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
Applicant
RADIONICS, INC.
76 CAMBRIDGE ST.
BURLINGTON,  MA  01803
Applicant Contact LINDA JALBERT
Correspondent
RADIONICS, INC.
76 CAMBRIDGE ST.
BURLINGTON,  MA  01803
Correspondent Contact LINDA JALBERT
Regulation Number882.5550
Classification Product Code
JXG  
Date Received04/28/1997
Decision Date 07/24/1997
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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