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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 K003322
Device Name CODMAN BACTISEAL CATHETERS
Applicant
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact JAMES M FLAHERTY
Correspondent
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact JAMES M FLAHERTY
Regulation Number882.4100
Classification Product Code
HCA  
Date Received10/24/2000
Decision Date 10/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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