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FDA 510(k) Application Details - K033159
Device Classification Name
Catheter, Intravascular Occluding, Temporary
More FDA Info for this Device
510(K) Number
K033159
Device Name
Catheter, Intravascular Occluding, Temporary
Applicant
LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON, MA 01803 US
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Contact
BRIAN K KEOGH
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
MJN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2003
Decision Date
12/19/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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