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FDA 510(k) Application Details - K983758
Device Classification Name
Clip, Aneurysm
More FDA Info for this Device
510(K) Number
K983758
Device Name
Clip, Aneurysm
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO, CA 94080 US
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Contact
VICTORIA MACKINNON
Other 510(k) Applications for this Contact
Regulation Number
882.5200
More FDA Info for this Regulation Number
Classification Product Code
HCH
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More FDA Info for this Product Code
Date Received
10/26/1998
Decision Date
12/18/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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