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FDA 510(k), K191421, Sofacia System
FDA 510(k), K191421, Sofacia System
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510(K) Number: K191421
Device Name: Sofacia System
Manufacturer: Ruthie Amir
Device Classification Name: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Regulation Number: OHV
Classification Product Code: 05/28/2019
Date Received: 09/09/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Sofacia System
Manufacturer: Ruthie Amir
Device Classification Name: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Regulation Number: OHV
Classification Product Code: 05/28/2019
Date Received: 09/09/2019
Decision Date: Substantially Equivalent (SESE)
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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