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.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the cfb (coherent fiber bundle) fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the cfb (coherent fiber bundle).In addition, our technician confirmed that the insertion flexible tube coating damage, and the bending rubber perforated; however, these defects 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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