LifeStyles® SKYN® Intimate Moments Personal Lubricant

Lubricant, Personal

SXWELL USA LLC

The following data is part of a premarket notification filed by Sxwell Usa Llc with the FDA for Lifestyles® Skyn® Intimate Moments Personal Lubricant.

Pre-market Notification Details

• Device ID: K172473
• 510k Number: K172473
• Device Name: LifeStyles® SKYN® Intimate Moments Personal Lubricant
• Classification: Lubricant, Personal
• Applicant: SXWELL USA LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830
• Contact: Robert Mahler
• Correspondent: Robert Mahler; SXWELL USA LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830
• Product Code: NUC
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-15
• Decision Date: 2017-12-15
• Summary: summary