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FDA 510(k) Application Details - K173271
Device Classification Name
Applier, Aneurysm Clip
More FDA Info for this Device
510(K) Number
K173271
Device Name
Applier, Aneurysm Clip
Applicant
Aesculap, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact
Paul Amudala
Other 510(k) Applications for this Contact
Regulation Number
882.4175
More FDA Info for this Regulation Number
Classification Product Code
HCI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/12/2017
Decision Date
11/10/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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