LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT— 510(k) K122476
Substantially EquivalentAnsell Healthcare Products, LLC
FDA 510(k) clearance K122476 for LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT, Substantially Equivalent on 2013-03-07. Applicant: Ansell Healthcare Products, LLC. Device class: 2.
Clearance details
- Applicant
- Ansell Healthcare Products, LLC
- Product code
- Code NUC
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Luis Obispo, CA, US
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Adverse events under product code NUC
product code NUC- Other
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.