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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name shunt, central nervous system and components
510(k) Number K120559
Device Name AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
Original Applicant
AESCULAP, INC.
3773 corporate parkway
center valley,  PA  18034
Original Contact kathy a racosky
Regulation Number882.5550
Classification Product Code
JXG  
Date Received02/24/2012
Decision Date 05/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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