HOW THE FDA CLASSIFIES PERSONAL LUBRICANTS AND WHAT IS AN FDA 510(K)? United States Food and Drug Administration (FDA) Medical Device Classification System FDA Advisory No.2021 1504 Public Health Warning Against the Purchase and Use of the following Unnotified Medical Device Products Food and Drug Administration August 27, 2018 United Consortium Stephanie Morris Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355 Re: K1814 PERSONAL LUBRICANTS: CLASS II MEDICAL DEVICES
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