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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 K980903
Device Name RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
Applicant
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2516
Applicant Contact MICHAEL A ARNOLD, PH.D
Correspondent
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2516
Correspondent Contact MICHAEL A ARNOLD, PH.D
Regulation Number882.5550
Classification Product Code
JXG  
Date Received03/10/1998
Decision Date 04/19/1999
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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