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FDA 510(k), K153698, LumenR Tissue Retractor System
FDA 510(k), K153698, LumenR Tissue Retractor System
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$149.00 USD
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510(K) Number: K153698
Device Name: LumenR Tissue Retractor System
Manufacturer: LumenR, LLC
Device Classification Name: endoscopic contamination prevention sheath
Regulation Number: 876.1500
Classification Product Code: ODB
Date Received: 12/23/2015
Decision Date: 04/19/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: LumenR Tissue Retractor System
Manufacturer: LumenR, LLC
Device Classification Name: endoscopic contamination prevention sheath
Regulation Number: 876.1500
Classification Product Code: ODB
Date Received: 12/23/2015
Decision Date: 04/19/2016
Regulation Medical Specialty: Gastroenterology/Urology
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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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