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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name strip, craniosynostosis, preformed
510(k) Number K033395
Device Name CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1
Applicant
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact LIZ DOLAN
Correspondent
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact LIZ DOLAN
Regulation Number882.5900
Classification Product Code
GXO  
Date Received10/23/2003
Decision Date 02/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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