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This product is a custom device made to meet the specific needs of an individual patient or physician. It is not generally available and is subject to the FDA's Custom Device Exemption under Section 520(b) of the FD&C Act. This product is for prescription use only. This is not a substitute for standard medical devices and should be used only as directed by a qualified healthcare provider. Use is restricted to sale by or on the order of a physician. This device is a custom device and is subject to FDA Custom Device Exemption regulations.
