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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 K912456
Device Name SUNDT SLIM-LINE GRAFT CLIPS
Applicant
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Applicant Contact JEANETTE CLOUTIER
Correspondent
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Correspondent Contact JEANETTE CLOUTIER
Regulation Number882.5200
Classification Product Code
HCH  
Date Received06/03/1991
Decision Date 03/10/1995
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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