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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 K984109
Device Name AESCULAP AXIAL CLIP APPLIER
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact LIA S JONES
Correspondent
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact LIA S JONES
Regulation Number882.4175
Classification Product Code
HCI  
Date Received11/17/1998
Decision Date 02/12/1999
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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