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 FDA Regulations Biomedical Engineering Research Guides at University of Alabama Birmingham United States Food and Drug Administration (FDA) Medical Device Classification System K Y Ultragel Premium Water based Personal Lubricant 1.5 oz, 1.5 fl oz Smith's Food and Drug
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