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FDA 510(k) Application Details - K132880
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K132880
Device Name
Set, Administration, Intravascular
Applicant
MEDICAL COMPONENTS INC
1499 DELP DRIVE
HARLEYSVILLE, PA 19438 US
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Contact
TIMOTHY HOLWICK
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2013
Decision Date
01/08/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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