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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 K962990
Device Name RADIONICS SIPHON LIMITING DEVICE (SLD)
Applicant
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
Applicant Contact MICHAEL ARNOLD, PH.D.
Correspondent
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
Correspondent Contact MICHAEL ARNOLD, PH.D.
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/01/1996
Decision Date 10/23/1996
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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