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FDA 510(k), K193007, LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
FDA 510(k), K193007, LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
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510(K) Number: K193007
Device Name: LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
Manufacturer: Jaroslaw Mrówczynski
Device Classification Name: Hysteroscope (And Accessories)
Regulation Number: HIH
Classification Product Code: 10/28/2019
Date Received: 01/17/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
Manufacturer: Jaroslaw Mrówczynski
Device Classification Name: Hysteroscope (And Accessories)
Regulation Number: HIH
Classification Product Code: 10/28/2019
Date Received: 01/17/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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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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