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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 K190174
Device Name Miethke Shunt System GAV 2.0 and SA 2.0 Valves
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 Received02/01/2019
Decision Date 07/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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