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FDA 510(k), K181859, Visualase Thermal Therapy System
FDA 510(k), K181859, Visualase Thermal Therapy System
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510(K) Number: K181859
Device Name: Visualase Thermal Therapy System
Manufacturer: Rishi Sinha
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: 07/12/2018
Date Received: 03/06/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Visualase Thermal Therapy System
Manufacturer: Rishi Sinha
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: 07/12/2018
Date Received: 03/06/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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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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