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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 K954658
Device Name PERNECZKY CLIP APPLIER/REMOVER
Applicant
VON ZEPPELIN GMBH
GISTLSTRASSE 99
PULLACH,  DE D-82049
Applicant Contact DIETER VON ZEPPELIN
Correspondent
VON ZEPPELIN GMBH
GISTLSTRASSE 99
PULLACH,  DE D-82049
Correspondent Contact DIETER VON ZEPPELIN
Regulation Number882.4175
Classification Product Code
HCI  
Date Received10/10/1995
Decision Date 10/08/1996
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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