FDA Advisory No.2021 1897 Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product RITE CARE PERSONAL LUBRICANT WATER SOLUBLE LUBRICATING GEL Food and Drug Administration October 20, 2015 Package Solutions LLC Jack Scalisi Director Of Operations 2131 Blount Road Pompano Beach, Florida 33069 Re: K15 K Y Ultragel Premium Water based Personal Lubricant 1.5 oz, 1.5 fl oz Smith's Food and Drug HOW THE FDA CLASSIFIES PERSONAL LUBRICANTS AND WHAT IS AN FDA 510(K)?
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personal lubricant fda classification 510K FDA Certification for Personal Lubricant Manufacturing