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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 K183256
Device Name GlideScope BFlex Single-Use Bronchoscope System
Applicant
Verathon Medical (Canada) ULC
2227 Douglas Road
Burnaby,  CA V3W 1P2
Applicant Contact Teresa Davidson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received11/21/2018
Decision Date 01/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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