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(B) Such summary information may include: (i) declaration or certificate of conformity to ...

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This summary may include: (a) Where a recognized standard exists, a declaration/certificat...

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Ethics Committee This section shall document that the clinical investigation was conducted...

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9.2 Reproducibility: This section should include reproducibility estimates and information...

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(ii) Detailed information: Detailed information should include: (a) complete study protoco...

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(ii) Detailed information: Detailed information should include: (a) complete study protoco...

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1.2 Information regarding sterilization of the device (whether it is sterile or non-steril...

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CLINICAL INVESTIGATION REPORT 1. General This table specifies the contents of the clinical...

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Reproducibility: This section should include reproducibility estimates and information abo...

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