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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 K060915
Device Name KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
Applicant
Kirwan Surgical Products, Inc.
180 Enterprise Dr.
Marshfield,  MA  02050
Applicant Contact KEVIN P PRARIO
Correspondent
Kirwan Surgical Products, Inc.
180 Enterprise Dr.
Marshfield,  MA  02050
Correspondent Contact KEVIN P PRARIO
Regulation Number882.5200
Classification Product Code
HCH  
Date Received04/04/2006
Decision Date 04/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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