This device is classified as import for export, therefore 510k is not applicable.Model ec38-i10l-us is available in the usa with a 510k number k131855.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the water jet tube clogged.Based on the result, we concluded that it was caused due to the inadequate insufficient reprocessing at the facility on the water jet tube.Based on the technical report ""hr-rpt-0630 (air/water & jet water channels)"" and or the risk analysis results, it was evaluated to submit mdr.
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