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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 K893395
Device Name MINI-MONITOR J7000 ICP
Applicant
Ladd Research Industries, Inc.
P.O. Box 1005
Burlington,  VT  05402
Applicant Contact JOHN ARNOTT
Correspondent
Ladd Research Industries, Inc.
P.O. Box 1005
Burlington,  VT  05402
Correspondent Contact JOHN ARNOTT
Regulation Number882.1620
Classification Product Code
GWM  
Date Received05/01/1989
Decision Date 11/22/1989
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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