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FDA 510(k) Application Details - K191948
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K191948
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
Verathon Medical (Canada) ULC
2227 Douglas Road
Burnaby V5C 5A9 CA
Other 510(k) Applications for this Company
Contact
Haleh Ghassemi
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/22/2019
Decision Date
08/21/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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