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Spenco Silicone Gel Sheet is indicated for: - Use as a scar management dressing on old and new 1. hyperthropic or keloid scars. - infected wounds Not to be used on ત્વે. - Is not indicated for use on 3rd degree burns - The device can be used by layman, safely when following the instructions-for use included with the product.

Spenco Silicone Gel Sheet

This document is an FDA 510(k) clearance letter for the Spenco Silicone Gel Sheet. It is not a study report, and therefore, it does not provide the detailed information requested regarding clinical studies, acceptance criteria, or performance data.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on substantial equivalence to a predicate device, not necessarily on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot extract the requested information from this document. The document primarily confirms the FDA's decision to allow the device to be marketed due to its substantial equivalence to an already legally marketed device.

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