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While folliculitis is generally not a serious health threat, it can be uncomfortable and may lead to secondary infections if not managed properly

medication mix and pricing are confirmed during the medical evaluation

Florida APRN #11005134) does exactly that and the rules are moving fast

Several commenters stated that 510(k) clearance follows a less intensive pathway than PMA but emphasized that the FDA would never permit any device for market use unless the 510(k) submission sufficiently demonstrates patient safety and clinical efficacy