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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name methyl methacrylate for aneurysmorrhaphy
510(k) Number K071776
Device Name ANEUROPLASTIC, MODEL 43-1290
Applicant
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact RACHEL CREME
Correspondent
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact RACHEL CREME
Regulation Number882.5030
Classification Product Code
JXH  
Date Received06/29/2007
Decision Date 07/26/2007
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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