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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. 2050 Regulatory Class Class II Product Code LLZ Dated August 4 2015 Received August 5 2015 Dear Mr. Its intended uses are similar to those of the predicate. Element 510 k owner Supports mammography Operating System Predicate McKesson K043146 Horizon Medical Imaging Yes. Com June 15 2015 Revised July 17 2015 Class II per 21...
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