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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 K023902
Device Name SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
Applicant
Usgi Medical, Inc.
2 Delphinus
Irvine,  CA  92612
Applicant Contact JUDY F GORDON
Correspondent
Usgi Medical, Inc.
2 Delphinus
Irvine,  CA  92612
Correspondent Contact JUDY F GORDON
Regulation Number876.1500
Classification Product Code
FED  
Subsequent Product Code
FDF  
Date Received11/22/2002
Decision Date 08/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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