FDA 510(k) Application Details - K150951

Device Classification Name Bronchoscope Accessory

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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
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Regulation Number 874.4680

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Classification Product Code KTI
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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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