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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K130507
Device Name FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
Applicant
FOOTPRINT MEDICAL INC.
12727 CIMARRON PATH
SAN ANTONIO,  TX  78249
Applicant Contact CLYDE N BAKER
Correspondent
FOOTPRINT MEDICAL INC.
12727 CIMARRON PATH
SAN ANTONIO,  TX  78249
Correspondent Contact CLYDE N BAKER
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/27/2013
Decision Date 06/03/2013
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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