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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 K091213
Device Name FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
Applicant
FOOTPRINT MEDICAL
1203 CAMDEN ST.
SAN ANTONIO,  TX  78215
Applicant Contact CLYDE BAKER
Correspondent
FOOTPRINT MEDICAL
1203 CAMDEN ST.
SAN ANTONIO,  TX  78215
Correspondent Contact CLYDE BAKER
Regulation Number880.5200
Classification Product Code
FOS  
Date Received04/27/2009
Decision Date 09/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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