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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
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