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The filters were found to be substantially equivalent to the predicate DSU-H and SSU-H Ultrafilters K141731. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. 5665 Water Purification Device General and Number Medical Use NHV Predicate Device DSU-H and SSU-H Ultrafilters K141731 Device Description Intended Use quality drinking water. Prescription Use X Part 21 CFR 801...
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