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EXCEED ALL requirements of: |
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FDA 510K (USA pre market notification for Class 1 medical devices) |
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CE Mark (compliance with European Standards for clear vinyl) |
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COMPLY WITH ALL requirements of: |
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US Code of Federal Regulations, Title 21, Part 177.2600 |
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BEEN NOTIFIED on the New Zealand MEDSAFE database for Medical Devices: |
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As required by the Medicines Regulations 2003 |