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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 K051919
Device Name MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
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
FDF  
Date Received07/15/2005
Decision Date 07/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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