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FDA 510(k), K211676, Motiva Flora SmoothSilk Tissue Expander
FDA 510(k), K211676, Motiva Flora SmoothSilk Tissue Expander
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$149.00 USD
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510(K) Number: K211676
Device Name: Motiva Flora SmoothSilk Tissue Expander
Manufacturer: Roslyn d'Incelli
Device Classification Name: Tissue Expander And Accessories
Regulation Number: LCJ
Classification Product Code: 06/01/2021
Date Received: 10/13/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Motiva Flora SmoothSilk Tissue Expander
Manufacturer: Roslyn d'Incelli
Device Classification Name: Tissue Expander And Accessories
Regulation Number: LCJ
Classification Product Code: 06/01/2021
Date Received: 10/13/2023
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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