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FDA 510(k), K160470, SculpSure
FDA 510(k), K160470, SculpSure
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$149.00 USD
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510(K) Number: K160470
Device Name: SculpSure
Manufacturer: CYNOSURE, INC.
Device Classification Name: Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Regulation Number: 878.5400
Classification Product Code: PKT
Date Received: 02/19/2016
Decision Date: 07/21/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SculpSure
Manufacturer: CYNOSURE, INC.
Device Classification Name: Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Regulation Number: 878.5400
Classification Product Code: PKT
Date Received: 02/19/2016
Decision Date: 07/21/2016
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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