FDA 510(k), K173756, Certus 140 2.45GHz Ablation System
FDA 510(k), K173756, Certus 140 2.45GHz Ablation System
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
Total pages: 2141
Fully redacted pages: 1459
Content pages: 682
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