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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 K090348
Device Name CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
Applicant
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Applicant Contact SHARON MCDERMOTT
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent Contact SHARON MCDERMOTT
Regulation Number882.5550
Classification Product Code
JXG  
Date Received02/11/2009
Decision Date 03/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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