FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming
K Number: K200457
·
Decision May 22, 2020
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
12
Review Days
87
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Basic Information
- Device Name
- Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming
- K Number
- K200457
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CC Wellness, LLC
- Date Received
- February 25, 2020
- Decision Date
- May 22, 2020
- Product Code
- NUC
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUC | Lubricant, Personal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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