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FDA 510(k), K173405, DiLumen Endolumenal Interventional Scissors (DiLumen Is)
FDA 510(k), K173405, DiLumen Endolumenal Interventional Scissors (DiLumen Is)
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510(K) Number: K173405
Device Name: DiLumen Endolumenal Interventional Scissors (DiLumen Is)
Manufacturer: Lumendi, LLC
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 10/31/2017
Decision Date: 05/22/2018
Regulation Medical Specialty: General & Plastic Surgery
Device Name: DiLumen Endolumenal Interventional Scissors (DiLumen Is)
Manufacturer: Lumendi, LLC
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 10/31/2017
Decision Date: 05/22/2018
Regulation Medical Specialty: General & Plastic Surgery
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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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