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FDA 510(k) Application Details - K072248
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K072248
Device Name
Introducer, Catheter
Applicant
ENPATH MEDICAL, INC.
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS, MN 55441 US
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Contact
PATRICE STROMBERG
Other 510(k) Applications for this Contact
Regulation Number
870.1340
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Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
08/13/2007
Decision Date
11/09/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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