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FDA 510(k), K214125, TRANBERG Thermoguide Therapy System
FDA 510(k), K214125, TRANBERG Thermoguide Therapy System
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510(K) Number: K214125
Device Name: TRANBERG Thermoguide Therapy System
Manufacturer: Clinical Laserthermia Systems AB
Device Classification Name: Neurosurgical Laser With Mr Thermography
Regulation Number: 878.4810
Classification Product Code: ONO
Date Received: 12/30/2021
Decision Date: 09/22/2022
Regulation Medical Specialty: General & Plastic Surgery
Device Name: TRANBERG Thermoguide Therapy System
Manufacturer: Clinical Laserthermia Systems AB
Device Classification Name: Neurosurgical Laser With Mr Thermography
Regulation Number: 878.4810
Classification Product Code: ONO
Date Received: 12/30/2021
Decision Date: 09/22/2022
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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