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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 K091773
Device Name FUJINON STERILE OVERTUBES
Applicant
Fujinon, Inc.
80 Shelton Technology Center
Shelton,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
Fujinon, Inc.
80 Shelton Technology Center
Shelton,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number876.1500
Classification Product Code
FED  
Date Received06/16/2009
Decision Date 08/07/2009
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
Predetermined Change
Control Plan Authorized		 No
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