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K201060-S001.Letter.SE.pdf
... ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or ... the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device ... ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or ... the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device ...
