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FDA 510(k), K173756, Certus 140 2.45GHz Ablation System
FDA 510(k), K173756, Certus 140 2.45GHz Ablation System
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510(K) Number: K173756
Device Name: Certus 140 2.45GHz Ablation System
Manufacturer: Dan Kosednar
Device Classification Name: System, Ablation, Microwave And Accessories
Regulation Number: NEY
Classification Product Code: KXA
Date Received: 12/11/2017
Decision Date: 10/24/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Certus 140 2.45GHz Ablation System
Manufacturer: Dan Kosednar
Device Classification Name: System, Ablation, Microwave And Accessories
Regulation Number: NEY
Classification Product Code: KXA
Date Received: 12/11/2017
Decision Date: 10/24/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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