FDA Advisory No.2022 1042 Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product SPECIFIED BRAND OF WATER BASED PERSONAL LUBRICANT Food and Drug Administration PERSONAL LUBRICANTS: CLASS II MEDICAL DEVICES October 20, 2015 Package Solutions LLC Jack Scalisi Director Of Operations 2131 Blount Road Pompano Beach, Florida 33069 Re: K15 United States Food and Drug Administration (FDA) Medical Device Classification System FDA Classification Overview for Digital Health Products Digital Medicine Society (DiMe) K Y Ultragel Premium Water based Personal Lubricant 1.5 oz, 1.5 fl oz Smith's Food and Drug
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