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FDA 510(k) Application Details - K220606
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K220606
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup 2750 DK
Other 510(k) Applications for this Company
Contact
Gurpreet Kaur Rehal
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
03/02/2022
Decision Date
07/25/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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