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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 K844834
Device Name MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1
Applicant
MACHIDA AMERICA, INC.
40 RAMLAND RD.
ORANGEBURG,  NY  10962
Applicant Contact RON PELL
Correspondent
MACHIDA AMERICA, INC.
40 RAMLAND RD.
ORANGEBURG,  NY  10962
Correspondent Contact RON PELL
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received12/12/1984
Decision Date 06/11/1985
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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