LisaMadison Banned

  • Member since Jul 29th 2024
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A new update is now available, introducing "Points of interest" and many more changes!
Latest hotfix: 0.9 (2025-11-05)

  • 510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc. U.S. Medical Device 510(k) Premarket Notification