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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
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