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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 K010908
Device Name MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
Applicant
MEDICON, E.G.
GAENSAECKER 15
TUTTLINGEN,  DE D-78532
Applicant Contact JOACHIM SCHMID
Correspondent
MEDICON, E.G.
GAENSAECKER 15
TUTTLINGEN,  DE D-78532
Correspondent Contact JOACHIM SCHMID
Regulation Number882.5200
Classification Product Code
HCH  
Date Received03/26/2001
Decision Date 08/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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