FDA 510(k) Application Details - K202346

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K202346
Device Name Bronchoscope (Flexible Or Rigid)
Applicant Veran Medical Technologies, Inc.
1908 Innerbelt Business Center Dr
St. Louis, MO 63114 US
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Contact B. Nathan Hunt
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 08/18/2020
Decision Date 02/19/2021
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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