Pentax model eg29-i10c is classified as import for export, therefore 510k is not applicable.Pentax same model eg29-i10c-us is distributed in the usa with 510k k190805.If additional information becomes available, a supplemental report will be filed with the new information.
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Pentax medical became aware of a report for an event which occurred in (b)(6) stating, "poor image illumination" involving pentax model eg29-i10c/serial (b)(4).No further information was provided at the time of the report.The device was returned to pentax medical service workshop in (b)(4) where the following was confirmed: a/w connector at the lg plug leaky.Lg-plug water damage, pcb corroded.Foggy, misty image detected after minor repair at final inspection at the workshop.The distal end assy will be replaced.
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