(b)(4).Device evaluation summary: investigation summary: it was reported that the device had foreign matter issues.There was no sample received for analysis.Only a picture of the sample was received for analysis.During the visual inspection of the picture, a sample of product code 2829 could be observed and no foreign matter were noted.However, no conclusion could be reach as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.
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