Claude Code
Codex
Cursor
GitHub Copilot
Gemini CLIAbout this skill
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.
Quick start
- Copy the install prompt. Use the green button above this README.
- Send it to your agent. Paste it into your coding agent’s chat and send.
- Review the setup. Your agent checks the skill’s instructions, requirements, and installation scope.
Review, license & listing details
Review the source before using this skill
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About scan coverage and limitationsAbout this listing
- Category
- General
- Reported license
- Apache-2.0
- Listing language (estimated)
- English
- Review status
- Not individually reviewed
- Agent compatibility
- Atlas installation supports Claude Code, Codex, and Cursor. Skill-specific dependencies and features are checked during setup.