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 FDA Medical Device Classification: How To Determine Your Device Class Orangesoft United States Food and Drug Administration (FDA) Medical Device Classification System
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