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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 K003759
Device Name AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
Applicant
AESCULAP, INC.
200 GREGORY LN.
SUITE C-100
PLEASENT HILL,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
AESCULAP, INC.
200 GREGORY LN.
SUITE C-100
PLEASENT HILL,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Regulation Number882.1620
Classification Product Code
GWM  
Date Received12/06/2000
Decision Date 06/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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