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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 K151315
Device Name Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
Applicant
BOSTON SCIENTIFIC CORPORATION
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact YINGYING GAO
Correspondent
BOSTON SCIENTIFIC CORPORATION
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact YINGYING GAO
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received05/18/2015
Decision Date 11/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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