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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 K933433
Device Name MODIFIED BRONCHOSCOPE AND ACCESSORIES
Applicant
FUJINON, INC.
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Applicant Contact GARY A ADLER
Correspondent
FUJINON, INC.
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Correspondent Contact GARY A ADLER
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received07/14/1993
Decision Date 11/01/1993
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
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