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

Total pages: 2141
Fully redacted pages: 1459
Content pages: 682

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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