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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 K211030
Device Name EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Carter Navarro
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Carter Navarro
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/06/2021
Decision Date 08/09/2021
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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