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FDA 510(k) Application Details - K213434
Device Classification Name
Bronchoscope Accessory
More FDA Info for this Device
510(K) Number
K213434
Device Name
Bronchoscope Accessory
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095 US
Other 510(k) Applications for this Company
Contact
David Thomas
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
KTI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/22/2021
Decision Date
03/08/2022
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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