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Comment: A few commenters stated that requiring the proposed attester name data element would raise concern that any unintentional errors in the MRFs may be punitively attached to the name of a single person, including exposing hospital executives to excessive liability or public criticism over unintentional, technical variances

[46] The applicant also stated that the existing code C1889 (Implantable/insertable device, not otherwise classified) does not appropriately describe the VersaVue TM Single-Use Flexible Cystoscope

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