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FDA 510(k) Application Details - K000824
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K000824
Device Name
Introducer, Catheter
Applicant
MEDAMICUS, INC.
15301 HWY. 55 WEST
MINNEAPOLIS, MN 55447 US
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Contact
DENNIS MADISON
Other 510(k) Applications for this Contact
Regulation Number
870.1340
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Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/14/2000
Decision Date
04/13/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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