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FDA 510(k), K191369, TSolution One Total Knee Application
FDA 510(k), K191369, TSolution One Total Knee Application
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510(K) Number: K191369
Device Name: TSolution One Total Knee Application
Manufacturer: THINK Surgical, Inc.
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 05/22/2019
Decision Date: 10/08/2019
Regulation Medical Specialty: Neurology
Device Name: TSolution One Total Knee Application
Manufacturer: THINK Surgical, Inc.
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 05/22/2019
Decision Date: 10/08/2019
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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