FDA 510(k) Summary Request for K241361

Original Request: This FOIA Request is submitted for the following records: - 510(k) Summary for 510(k) Number K241361 The Requester would like to note that it has been over 30 days since the Decision Date, and in accordance with 21 CFR 807.95(d), "FDA will make a 510(k) summary of the safety and effectiveness data available to the public within 30 days of the issuance of a determination that the device is substantially equivalent to another device. Accordingly, even when a 510(k) submitter has complied with the conditions set forth in paragraphs (b) and (c) of this section, confidentiality for a premarket notification submission cannot be granted beyond 30 days after FDA issues a determination of equivalency."
Tags: MedTech, 510(k), 2024