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1. To be used for control of anterior nasal epistaxis.
2. To be used as a nasal packing following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.

The Epi-Stop™ is a single balloon catheter with integral airway designed for both nasal packing and control of anterior nasal hemorrhage. The Epi-Stop™ can be used to control the bleeding of an anterior epistaxis. As a packing, it can be used following septoplasty, rhinoplasty, and other intra-nasal surgical procedures. The Epi-Stop™ is supplied sterile and includes a 20cc syringe for balloon inflation.

This document is a 510(k) summary for the Epi-Stop™ Epistaxis Catheter. It describes the device, its intended use, and its predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary states that "Device is constructed using well-established medical grade silicone," implying that the device was deemed substantially equivalent to a predicate device based on material and design, rather than performance studies with acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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