October 20, 2015 Package Solutions LLC Jack Scalisi Director Of Operations 2131 Blount Road Pompano Beach, Florida 33069 Re: K15 FDA Advisory No.2021 1504 Public Health Warning Against the Purchase and Use of the following Unnotified Medical Device Products Food and Drug Administration OEM Custom Pure Grade Silicone Based Personal Lubricants Manufacturer 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