This device is classified as import for export, therefore 510k is not applicable.Model eb-1575k is available in the usa with a 510k number k131028.We checked the returned unit and confirmed that the operation channel blocked.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility on the operation channel.In addition, we confirmed that the lcb distal cover glass broken, the segment compressed, the lg prong corroded, the lcb distal cover glass leaky, and the distal body worn out; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0588(channel)"" and/or the risk analysis results, it was evaluated to submit mdr.
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