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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 K211947
Device Name GlideScope BFlex 2.8 Single-Use Bronchoscope
Applicant
Verathon Medical (Canada) Ulc
2227 Douglas Rd.
Burnaby,  CA V5C 5A9
Applicant Contact Teresa Davidson
Correspondent
Verathon Medical (Canada) Ulc
2227 Douglas Rd.
Burnaby,  CA V5C 5A9
Correspondent Contact Teresa Davidson
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/23/2021
Decision Date 11/03/2021
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
Predetermined Change
Control Plan Authorized		 No
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