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FDA 510(k) Application Details - K142934
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K142934
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
COVIDIEN
161 Cheshire Lane Suite 100
Plymouth, MN 55441 US
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Contact
Deborah Fleetham
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
10/09/2014
Decision Date
06/17/2015
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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