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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 K060554
Device Name CMA CEREBRAL TISSUE MONITORING SYSTEM
Applicant
CMA MICRODIALYSIS AB
73 PRINCETON STREET
NORTH CHELMSFORD,  MA  01863
Applicant Contact NANCY BLANCO
Correspondent
CMA MICRODIALYSIS AB
73 PRINCETON STREET
NORTH CHELMSFORD,  MA  01863
Correspondent Contact NANCY BLANCO
Regulation Number882.1620
Classification Product Code
GWM  
Date Received03/01/2006
Decision Date 05/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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