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FDA 510(k) Application Details - K150951
Device Classification Name
Bronchoscope Accessory
More FDA Info for this Device
510(K) Number
K150951
Device Name
Bronchoscope Accessory
Applicant
Bryan Medical , Inc.
3906 Oak St.
Cincinnati, OH 45227 US
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Contact
ANDY BLACK
Other 510(k) Applications for this Contact
Regulation Number
874.4680
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Classification Product Code
KTI
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More FDA Info for this Product Code
Date Received
04/09/2015
Decision Date
06/25/2015
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
Y
Expedited Review
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