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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 K013136
Device Name ANEURYSM CLIPS
Applicant
GISTLSTRASSE
GISTLSTRASSE 99
PULLACH,  DE 82049
Applicant Contact DIETER VON SEPPELIN
Correspondent
GISTLSTRASSE
GISTLSTRASSE 99
PULLACH,  DE 82049
Correspondent Contact DIETER VON SEPPELIN
Regulation Number882.5200
Classification Product Code
HCH  
Date Received09/19/2001
Decision Date 11/26/2001
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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