This device is classified as import for export, therefore 510k is not applicable.Model fnl-10rp3 is available in the usa with a 510k number k951196.We checked the returned unit and confirmed that the foggy image.Based on the result, we concluded that it was caused due to the moisture condensation in the objective cover lens broken.In addition, we confirmed that insertion flexible tube (ift) buckled and the insertion flexible tube (ift):the inside of the cable became to "spiral closer" condition, and the cable is lg cable or ift type.; however, they are (it is) not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
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