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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K063316
Device Name FUJINON MODEL EG-530N TRANS NASAL INSERTION
Applicant
Fujinon, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
Fujinon, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number876.1500
Classification Product Code
FDS  
Date Received11/02/2006
Decision Date 03/16/2007
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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