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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K022638
Device Name NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
Applicant
NEURORECOVERY, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
NEURORECOVERY, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number882.1620
Classification Product Code
GWM  
Date Received08/08/2002
Decision Date 10/31/2002
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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