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The applicant identified other devices it believes are closely related or similar to the VersaVue [TM] Single-Use Flexible Cystoscope, including the following: (1) Ambu aScope 4 [TM] Cysto manufactured by AMBU A/S, (2) Ambu aScope 5 [TM] Cysto manufactured by AMBU A/S, (3) WiScope SingleUse- Digital Flexible Cystoscope manufactured by OTU Medical AnQing, (4) Medical Single Use Flexible Cystoscope manufactured by Shanghai AnQing Medical Instrument Company, and (5) Pusen Single Use Flexible Video Cystoscope System manufactured by Zhuhai Pusen Medical Technology Company

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Missing or vague labeling suggests the product wasn't made under proper pharmaceutical controls