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Our 510k is definitely a sliver of the various forms of requirements that may be needed depending your product space and classification. We're hoping this repo
by koji 10y ago
Our 510k is definitely a sliver of the various forms of requirements that may be needed depending your product space and classification.
We're hoping this repo will grow as other contribute, and be a space where people can find references for various types of regulatory support.
If you'd like to contribute, we'd be happy to give you access.