(398 days)
For temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "STAR Temporary Wound Cover." It primarily deals with the regulatory approval process and doesn't contain information about specific acceptance criteria, study details, or device performance metrics as requested in the prompt. The letter states that the device is "substantially equivalent" to previously marketed devices, but it does not specify the quantitative performance metrics or studies used to demonstrate this equivalence.
Therefore, I cannot provide the requested information from this document. The document primarily confirms regulatory clearance based on substantial equivalence, rather than detailing a specific performance study.
§ 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.