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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
MUHLHEIM, BADEN-WURTTEMBERG,  DE 78570
Applicant Contact FRANZ MENEAN
Correspondent
PETER LAZIC GMBH
GRIESWEG 47
MUHLHEIM, BADEN-WURTTEMBERG,  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
Recalls CDRH Recalls
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