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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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