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FDA 510(k) Application Details - K130896
Device Classification Name
Dilator, Vessel, Surgical
More FDA Info for this Device
510(K) Number
K130896
Device Name
Dilator, Vessel, Surgical
Applicant
SYNOVIS LIFE TECHNOLOGIES, INC.
2575 UNIVERSITY AVE. W.
ST. PAUL, MN 55114 US
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Contact
STEPHANI K AYALA
Other 510(k) Applications for this Contact
Regulation Number
870.4475
More FDA Info for this Regulation Number
Classification Product Code
DWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/2013
Decision Date
04/24/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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