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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Umbilical Artery
510(k) Number K120304
Device Name FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
Applicant
Footprint Medical, Inc.
1203 Camden St.
San Antonio,  TX  78215
Applicant Contact CLYDE BAKER
Correspondent
Footprint Medical, Inc.
1203 Camden St.
San Antonio,  TX  78215
Correspondent Contact CLYDE BAKER
Regulation Number880.5200
Classification Product Code
FOS  
Date Received02/01/2012
Decision Date 03/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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