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Anaphylaxis following a B12 injection has been documented in medical literature, particularly in patients with a sensitivity to cobalt or cobalamin compounds

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Finally, we disagree with the applicant that the evidence for the VersaVue TM Single-Use Flexible Cystoscope is equivalent to that used for Uretero1 TM , and, as we previously explained in the CY 2024 and CY 2025 OPPS/ASC final rules with comment period for Ambu aScope TM 5 Broncho HD (88 FR 81736) and Ambu aScope TM Gastro (89 FR 94182), and as discussed in more detail in our responses to comment, we evaluate all evidence submitted for each device pass-through application as it applies to the nominated device