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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 K081489
Device Name L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
Applicant
Peter Lazic GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Applicant Contact FRANZ MENEAN
Correspondent
Peter Lazic GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Correspondent Contact FRANZ MENEAN
Regulation Number882.5200
Classification Product Code
HCH  
Subsequent Product Code
HCI  
Date Received05/28/2008
Decision Date 09/25/2008
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
Recalls CDRH Recalls
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