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FDA 510(k), K163105, Emprint Ablation System
FDA 510(k), K163105, Emprint Ablation System
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510(K) Number: K163105
Device Name: Emprint Ablation System
Manufacturer: COVIDIEN LLC
Device Classification Name: system, ablation, microwave and accessories
Regulation Number: 878.4400
Classification Product Code: NEY
Date Received: 11/07/2016
Decision Date: 12/06/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Emprint Ablation System
Manufacturer: COVIDIEN LLC
Device Classification Name: system, ablation, microwave and accessories
Regulation Number: 878.4400
Classification Product Code: NEY
Date Received: 11/07/2016
Decision Date: 12/06/2016
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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