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FDA 510(k), K193202, EXALT Model D Single-Use Duodenoscope, EXALT Controller
FDA 510(k), K193202, EXALT Model D Single-Use Duodenoscope, EXALT Controller
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510(K) Number: K193202
Device Name: EXALT Model D Single-Use Duodenoscope, EXALT Controller
Manufacturer: Carter Navarro
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: FDT
Classification Product Code: KXA
Date Received: 11/20/2019
Decision Date: 12/13/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: EXALT Model D Single-Use Duodenoscope, EXALT Controller
Manufacturer: Carter Navarro
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: FDT
Classification Product Code: KXA
Date Received: 11/20/2019
Decision Date: 12/13/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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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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