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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, aneurysm
510(k) Number K091921
Device Name CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
Applicant
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact PAUL AMARAL
Correspondent
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact PAUL AMARAL
Regulation Number882.5200
Classification Product Code
HCH  
Date Received06/30/2009
Decision Date 09/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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