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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 -1794
Applicant Contact DONALD A LINCOLN
Correspondent
Codman & Shurtleff, Inc.
41 PACELLA PARK DR.
RANDOLPH INDUSTRIAL PARK
RANDOLPH,  MA  02368 -1794
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
Recalls CDRH Recalls
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