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FDA 510(k) Application Details - K183085
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K183085
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
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Contact
Elena Nieves
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
11/06/2018
Decision Date
03/08/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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