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Contract analysis / substantial-equivalence-comparison-draft.xlsx

substantial-equivalence-comparison-draft.xlsx

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[sheet: Cover]

[sheet: Cover] Field | Value Document Title | Substantial Equivalence Comparison Table Subject Device | Solstice Lumina™ CGM System (Lumina C14 Sensor & Lumina R7 Reader/Transmitter) Applicant | Solstice Biomedical Inc. Applicant Address | 220 Westbrook Drive, Suite 400, Cambridge, MA 02142 Delaware File No. | 7834291 Parent Entity | Solstice Biomedical Devices Ltd., Unit 14, Liffey Innovation Park, Chapelizod, Dubli