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FDA 510(k) Application Details - K130687
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K130687
Device Name
Introducer, Catheter
Applicant
MEDICAL COMPONENTS INC
1499 DELP DRIVE
HARLEYSVILLE, PA 19438 US
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Contact
JESSICA LEO
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
03/13/2013
Decision Date
08/15/2013
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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