FDA 510(k) Application Details - K170759

Device Classification Name Bronchoscope Accessory

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510(K) Number K170759
Device Name Bronchoscope Accessory
Applicant Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
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Contact Jia Huang
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Regulation Number 874.4680

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Classification Product Code KTI
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Date Received 03/13/2017
Decision Date 06/23/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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