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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 K191948
Device Name GlideScope BFlex 5.8 Single-Use Bronchoscope
Applicant
Verathon Medical (Canada) ULC
2227 Douglas Road
Burnaby,  CA V5C 5A9
Applicant Contact Haleh Ghassemi
Correspondent
Verathon Medical (Canada) ULC
2227 Douglas Road
Burnaby,  CA V5C 5A9
Correspondent Contact Haleh Ghassemi
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received07/22/2019
Decision Date 08/21/2019
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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