Device used for treatment, not diagnosis.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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