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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applier, Aneurysm Clip
510(k) Number K010910
Device Name MEDICON YASARGIL CLIP APPLYING FORCEPS
Applicant
Medicon EG
Gaensaecker 15
Tuttlingen,  DE D-78532
Applicant Contact JOACHIM SCHMID
Correspondent
Medicon EG
Gaensaecker 15
Tuttlingen,  DE D-78532
Correspondent Contact JOACHIM SCHMID
Regulation Number882.4175
Classification Product Code
HCI  
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
Predetermined Change
Control Plan Authorized		 No
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