Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant— 510(k) K200602
Substantially EquivalentCC Wellness, LLC
FDA 510(k) clearance K200602 for Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant, Substantially Equivalent on 2020-06-03. Applicant: CC Wellness, LLC. Device class: 2.
Clearance details
- Applicant
- CC Wellness, 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
- Valencia, CA, US
Recent devices under product code NUC
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view all- K232091 — JO Coconut Hybrid Cooling Personal Lubricant
- K232090 — JO Coconut Hybrid Warming Personal Lubricant
- K230674 — JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
- K221908 — JO CUMPLAY Personal Lubricant
- K212885 — Actively Trying Personal Lubricant Rose Scented
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.