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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applier, Aneurysm Clip
510(k) Number K902544
Device Name SUNDT AVM MICRO CLIP
Applicant
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368 -1794
Applicant Contact DONALD A LINCOLN
Correspondent
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368 -1794
Correspondent Contact DONALD A LINCOLN
Regulation Number882.4175
Classification Product Code
HCI  
Date Received06/06/1990
Decision Date 09/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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