(56 days)
The Proxiderm is intended to be utilized prior to a surgical procedure to remove a defect or prior to implantation of a prosthesis to provide additional skin for coverage of the defect or prosthesis.
Not Found
This is an FDA 510(k) clearance letter for a device called "Proxiderm." The letter states that the device is substantially equivalent to legally marketed predicate devices. However, the provided document does not contain any information about acceptance criteria, device performance, studies, sample sizes, expert qualifications, or ground truth.
Therefore, I cannot provide the requested table and study details. This document is a regulatory clearance, not a technical report or scientific study summary.
§ 878.4320 Removable skin clip.
(a)
Identification. A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.