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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K072405
Device Name USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
Applicant
USGI MEDICAL
1140 CALLE CORDILLERA
SAN CLEMENTE,  CA  92673
Applicant Contact MARY LOU MOONEY
Correspondent
USGI MEDICAL
1140 CALLE CORDILLERA
SAN CLEMENTE,  CA  92673
Correspondent Contact MARY LOU MOONEY
Regulation Number876.1500
Classification Product Code
FED  
Subsequent Product Code
ODB  
Date Received08/27/2007
Decision Date 09/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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