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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 K021653
Device Name CODMAN BACTISEAL EVD CATHETER SET
Applicant
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Applicant Contact KATHY WUNDER
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent Contact KATHY WUNDER
Regulation Number882.5550
Classification Product Code
JXG  
Date Received05/20/2002
Decision Date 07/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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