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Specialty Surgical Products Sterile Silicone Wound Covers are intended for external use in short term applications related to wound treatment by temporarily covering traumatic areas where primary closure attempts must be abandoned in favor of a staged repair.

Sterile Silicone External Wound Covers

This document is a 510(k) clearance letter from the FDA for a medical device called "Sterile Silicone External Wound Covers". It does not contain information about the acceptance criteria or results of a study as typically found in a clinical trial report or a performance study summary.

Therefore, I cannot provide the requested information. This document primarily focuses on the regulatory clearance of a device based on substantial equivalence, rather than detailed performance study data.

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