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FDA 510(k) Application Details - K120304
Device Classification Name
Catheter, Umbilical Artery
More FDA Info for this Device
510(K) Number
K120304
Device Name
Catheter, Umbilical Artery
Applicant
FOOTPRINT MEDICAL INC.
1203 CAMDEN STREET
SAN ANTONIO, TX 78215 US
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Contact
CLYDE BAKER
Other 510(k) Applications for this Contact
Regulation Number
880.5200
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Classification Product Code
FOS
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More FDA Info for this Product Code
Date Received
02/01/2012
Decision Date
03/01/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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