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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ventricular
510(k) Number K020728
Device Name MIETHKE SHUNT SYSTEM
Applicant
Aesculap, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact JOYCE KILROY
Correspondent
Aesculap, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact JOYCE KILROY
Regulation Number882.4100
Classification Product Code
HCA  
Date Received03/06/2002
Decision Date 04/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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