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FDA 510(k), K200678, PENTAX Medical Video Bronchoscope EB-J10 Series
FDA 510(k), K200678, PENTAX Medical Video Bronchoscope EB-J10 Series
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510(K) Number: K200678
Device Name: PENTAX Medical Video Bronchoscope EB-J10 Series
Manufacturer: William Goeller
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: EOQ
Classification Product Code: KXA
Date Received: 03/16/2020
Decision Date: 07/30/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: PENTAX Medical Video Bronchoscope EB-J10 Series
Manufacturer: William Goeller
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: EOQ
Classification Product Code: KXA
Date Received: 03/16/2020
Decision Date: 07/30/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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