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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 K040018
Device Name EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Applicant Contact JAMES D MCMAHON
Correspondent
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Correspondent Contact JAMES D MCMAHON
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received01/06/2004
Decision Date 01/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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