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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 K854581
Device Name MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
Applicant
MACHIDA AMERICA, INC.
40 RAMLAND RD.
ORANGEBURG,  NY  10962
Applicant Contact JAMES BRADLEY
Correspondent
MACHIDA AMERICA, INC.
40 RAMLAND RD.
ORANGEBURG,  NY  10962
Correspondent Contact JAMES BRADLEY
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received11/15/1985
Decision Date 02/28/1986
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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