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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K050907
Device Name FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
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 Number874.4680
Classification Product Code
EOQ  
Date Received04/11/2005
Decision Date 05/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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