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Single-dose study in lean cynomolgus monkeys Male cynomolgus monkeys (2 to 5 years old and weighing between 2.1 to 3.5 kg) were group housed (3 per cage) and acclimatized for at least 4 weeks prior to the study

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However, the device category codes referenced by the applicant were intentionally defined with anatomically specific descriptors from their inception ( e.g., C1748 (Endoscope, single-use ( i.e., disposable), upper GI, imaging/illumination device (insertable)) followed by C1747 (Endoscope, single use ( i.e., disposable), urinary tract, imaging/illumination device (insertable)), and C1601 (Endoscope, single-use ( i.e., disposable), pulmonary, imaging/illumination device (insertable)), as well as C1888 (Catheter, ablation, non-cardiac, endovascular (implantable)) followed by C1886 (Catheter, extravascular tissue ablation, any modality (insertable)))