(94 days)
The ePTFE Sheeting is intended for use in the augmentation or repair of the soft tissue of the facial area.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ePTFE Sheeting," which is a surgical mesh. This document grants market clearance based on substantial equivalence to a predicate device.
It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or any of the other details you are asking for.
Therefore, I cannot provide the requested information based on this input. It's likely that such information would be found in the actual 510(k) submission document itself, not in the clearance letter.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.