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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K102548
Device Name FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE
Applicant
Footprint Medical, Inc.
1203 Camden St.
San Antonio,  TX  78215
Applicant Contact CLYDE N BAKER
Correspondent
Footprint Medical, Inc.
1203 Camden St.
San Antonio,  TX  78215
Correspondent Contact CLYDE N BAKER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/03/2010
Decision Date 11/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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