ONE True Natural Water Based Personal Lubricant ONE Condoms PERSONAL LUBRICANTS: CLASS II MEDICAL DEVICES August 27, 2018 United Consortium Stephanie Morris Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355 Re: K1814 Medical Device Classification: Analysis of Global Standards FDA Advisory No.2021 1504 Public Health Warning Against the Purchase and Use of the following Unnotified Medical Device Products Food and Drug Administration United States Food and Drug Administration (FDA) Medical Device Classification System
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