This device is classified as import for export, therefore 510k is not applicable.Model eg38-j10ut-us is available in the usa with a 510k number k200090.We checked the returned unit and confirmed that the ccd module as defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the insertion flexible tube (ift) fluid damage, the u/d and the r/l pulley wires fluid damage, the ccd driver pcb fluid damage, the us connector body fluid damage, the light guide cable buckled, the suction channel buckled, the lg prong top corroded, the air/water channel leak, and the us connector cable lump/wave; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.
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