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These non-self-extinguishing mercury vapor and metal halide lamps failed to comply with the performance requirements of 21 CFR 1040.30 and the certification and identification requirements of 21 CFR 1010.2 and 1010.3
These non-self-extinguishing mercury vapor and metal halide lamps failed to comply with the performance requirements of 21 CFR 1040.30 and the certification and identification requirements of 21 CFR 1010.2 and 1010.3
Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution.