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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 K954285
Device Name CONTOUR FLEX VALVES (REGULAR & SMALL)
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 Received09/14/1995
Decision Date 01/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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