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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 (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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