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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 K031123
Device Name CODMAN BACTISEAL BARIUM STRIPED CATHETERS
Applicant
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact ELIZABETH DOLAN
Correspondent
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact ELIZABETH DOLAN
Regulation Number882.4100
Classification Product Code
HCA  
Date Received04/09/2003
Decision Date 05/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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