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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 K875205
Device Name TRI-FLOW CATHETER
Applicant
NEURODYNAMICS, INC.
P.O. BOX 603,
LENOX HILL STATION
NEW YORK,  NY  10021
Applicant Contact MARGARET MEADE
Correspondent
NEURODYNAMICS, INC.
P.O. BOX 603,
LENOX HILL STATION
NEW YORK,  NY  10021
Correspondent Contact MARGARET MEADE
Regulation Number882.5550
Classification Product Code
JXG  
Date Received12/18/1987
Decision Date 05/31/1988
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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