13 Feb Date February 13, 2025 Author Mr. Arunkumar Chokkalingam Case Study 1: U.S. Endotracheal Tube Manufacturer – Achieving 21 CFR 820 Compliance & 510(k) Submission with Medfins International. Client Background This case study focuses on a U.S.-based medical device manufacturer specializing in endotracheal tubes. The c...