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FDA 510(k) Application Details - K142097
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K142097
Device Name
Set, Administration, Intravascular
Applicant
BIOMEDIX, INC.
3895 WEST VERNAL PIKE
Blmgtn, IN 47404 US
Other 510(k) Applications for this Company
Contact
MYRA J BENDER
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
08/01/2014
Decision Date
08/29/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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