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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 Rd.
Burnaby,  CA V3W 1P2
Applicant Contact Teresa Davidson
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. 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
Predetermined Change
Control Plan Authorized		 No
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