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510k-premarket-notification

100 / 100 · Low risk

Fine to try.

By lev-os/agents (GitHub) · other · 28 stars · scanned at commit b247a6d

Drafts FDA 510(k) Premarket Notification submissions demonstrating substantial equivalence under 21 CFR Part 807. Supports Traditional, Special, and Abbreviated pathways. Use when preparing Class II medical device regulatory filings, substantial equivalence analyses, or FDA premarket submissions.

Works with any agent that supports SKILL.md skills.

What this skill can do

We found nothing in the files we read that matches our rules. That does not prove the skill is safe: see the limits of static scanning.

Install

Paste this into your terminal. It downloads exactly the version we scanned, not whatever is newest.

if [ -e ~/.agents/skills/'510k-premarket-notification' ] || [ -L ~/.agents/skills/'510k-premarket-notification' ]; then echo 'A skill folder named 510k-premarket-notification already exists — not replacing it' >&2; false; else d=$(mktemp -d) && git clone --quiet --filter=blob:none --no-checkout 'https://github.com/lev-os/agents' "$d" && git -C "$d" checkout --quiet 'b247a6df3094b3f2c2780c0f34a9f05925627ffc' -- 'skills-db/legal/510k-premarket-notification' && mkdir -p ~/.agents/skills && cp -R "$d"/'skills-db/legal/510k-premarket-notification' ~/.agents/skills/'510k-premarket-notification' && rm -rf "$d"; fi

Codex reads ~/.agents/skills directly. For Claude Code, Cursor, Copilot, Gemini CLI, Antigravity or OpenCode, also link it. For Claude Code: ln -s ~/.agents/skills/'510k-premarket-notification' ~/.claude/skills/'510k-premarket-notification' (other agents: ~/.cursor/skills, ~/.copilot/skills, ~/.gemini/skills, ~/.gemini/config/skills, ~/.config/opencode/skills). Or install through the finder skill, which does both.

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