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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 K161853
Device Name proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
Applicant
AESCULAP INC.
3773 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034
Applicant Contact KATHY A. RACOSKY
Correspondent
AESCULAP INC.
3773 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034
Correspondent Contact KATHY A. RACOSKY
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/06/2016
Decision Date 02/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT01885468
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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