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The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.

The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.

This document does not contain information regarding acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a Cauterization Smoke Evacuator, indicating that the device is substantially equivalent to legally marketed predicate devices. It primarily details regulatory information, product classification, and contact information for further inquiries.

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