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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 K180757
Device Name D-Clip; D-Clip Applier
Applicant
Peter Lazic GmbH
Immelmannweg 2
Tuttlingen,  DE 78532
Applicant Contact Sven Lazic
Correspondent
Peter Lazic GmbH
Immelmannweg 2
Tuttlingen,  DE 78532
Correspondent Contact Sven Lazic
Regulation Number882.5200
Classification Product Code
HCH  
Subsequent Product Code
HCI  
Date Received03/22/2018
Decision Date 04/12/2019
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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