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U -DQQH. DUMDODLQHQ CTO Microkatu 1 Kuopio 70211 FINLAND May 13 2016 Re K152020 Trade/Device Name Bindex BI-100 Regulation Number 21 CFR 892. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. DEVICE Name of Device Bindex Model BI-100 Common or Usual Name Bone sonometer Classification Name Bone sonometer 21 CFR 892. 1180 III. PREDICATE DEVICE BeamMed MiniOmni bone sonometer...

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Bone Index Finland Ltd is a medical technology company specializing in osteoporosis diagnosis and management.

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Bone Index Finland Ltd must report its financial performance, balance sheet, cash flow statement, and notes to the financial statements.

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