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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 K853770
Device Name CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
Applicant
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Applicant Contact DONALD A LINCOLN
Correspondent
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Correspondent Contact DONALD A LINCOLN
Regulation Number882.1620
Classification Product Code
GWM  
Date Received09/09/1985
Decision Date 10/06/1986
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
Recalls CDRH Recalls
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