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We supply supporting documentation, including batch-specific Certificates of Analysis (COAs), to confirm testing standards and product specifications

The compound does not affect glucose metabolism

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Further, the applicant explained that it did not assert that the VersaVue TM Single-Use Flexible Cystoscope offers a substantial clinical improvement compared to other single-use cystoscopes, stating that the substantial clinical improvement claims and evidence provided were in support of the category of single-use cystoscopes compared to reusable cystoscopes rather than the VersaVue TM Single-Use Flexible Cystoscope compared to other single-use, disposable cystoscopes or reusable cystoscopes