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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 K940970
Device Name YASARGIL, CASPAR, VARIO CLIP APPLIERS
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact VISTORIA MACKINNON
Correspondent
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact VISTORIA MACKINNON
Regulation Number882.4175
Classification Product Code
HCI  
Date Received03/02/1994
Decision Date 01/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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