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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 K983758
Device Name YASARGIL TITANIUM ANEURYSM CLIPS
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact VICTORIA MACKINNON
Correspondent
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact VICTORIA MACKINNON
Regulation Number882.5200
Classification Product Code
HCH  
Date Received10/26/1998
Decision Date 12/18/1998
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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