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FDA 510(k), K193517, ViziShot 2 FLEX
FDA 510(k), K193517, ViziShot 2 FLEX
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$149.00 USD
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510(K) Number: K193517
Device Name: ViziShot 2 FLEX
Manufacturer: Mary Anne Patella
Device Classification Name: Bronchoscope Accessory
Regulation Number: KTI
Classification Product Code: 12/19/2019
Date Received: 03/18/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: ViziShot 2 FLEX
Manufacturer: Mary Anne Patella
Device Classification Name: Bronchoscope Accessory
Regulation Number: KTI
Classification Product Code: 12/19/2019
Date Received: 03/18/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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