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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K090576
Device Name FOOTPRINT URINARY DRAINAGE CATHETER
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 Number876.5130
Classification Product Code
EZD  
Date Received03/03/2009
Decision Date 08/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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