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Hello, All,
Background
1) We have product already have 510(k) clearance.
2) We would like to have different proprietary name with only
Question
Hence, may we know if (in this case)
Background
1) We have product already have 510(k) clearance.
2) We would like to have different proprietary name with only
- enclosure color change &
- some labeling change (not related to warning, precaution, contraindication & also intended for use)
Question
Hence, may we know if (in this case)
- we can simply list this proprietary name under this 510(k) &
- keep the related documentation for this proprietary name in the same DMR of this product ?