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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 K954707
Device Name BRONCHOSCOPE
Applicant
Fujinon, Inc.
399 Park Ave.
New York,  NY  10022
Applicant Contact GARY A ADLER
Correspondent
Fujinon, Inc.
399 Park Ave.
New York,  NY  10022
Correspondent Contact GARY A ADLER
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received10/12/1995
Decision Date 11/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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